ATELLICA IM TOXOPLASMA IGG (TOXO G)
Report
- Report Number
- 1219913-2020-00118
- Event Type
- Malfunction
- Date Received
- May 8, 2020
- Date of Event
- April 22, 2020
- Report Date
- November 18, 2020
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Product Code
- LGD
- UDI-DI
- 00630414600123
- PMA / PMN Number
- K012183
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
SIEMENS FILED THE INITIAL MDR 1219913-2020-00118, REPORT ON (B)(6) 2020, FOR FALSE POSITIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS AND MDR 1219913-2020-00118, SUPPLEMENTAL REPORT 1 ON (B)(6) 2020, FOR A CORRECTION AND ADDITIONAL INFORMATION. (B)(6) 2020. ADDITIONAL INFORMATION: SIEMENS HAS REVIEWED ADDITIONAL TOXOPLASMA IGG (TOXO G) PATIENT DATA THROUGH (B)(6) 2020. THE RATE OF RESULT INTERPRETATIONS FOR REAGENT LOT 258, INCLUDING REAGENT LOT 260 RECOVER SIMILAR AND COMPARABLE WITH THE OTHER REAGENT LOTS REVIEWED. THE CALCULATED SPECIFICITY OBSERVED FOR TTHIS CUSTOMER FOR REAGENT LOT 258 IS 99.75% (395/396). THE INSTRUCTION FOR USE (IFU) INITIAL RELATIVE SPECIFICITY FROM 3 STUDIES RANGED FROM 97.7% TO 99.8 %. THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "THE MAGNITUDE OF THE MEASURED RESULT ABOVE THE CUT-OFF VALUE IS NOT INDICATIVE OF THE TOTAL AMOUNT OF ANTIBODY PRESENT IN THE SAMPLE.THE DETECTION OF TOXOPLASMA IGG IN A GIVEN SPECIMEN, AS DETERMINED BY ASSAYS FROM DIFFERENT MANUFACTURERS, CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY." SIEMENS CONTINUES TO INVESTIGATE. MDR 1219913-2020-00113, SUPPLEMENTAL REPORT 2 , MDR 1219913-2020-00114, SUPPLEMENTAL REPORT 2, MDR 1219913-2020-00117, SUPPLEMENTAL REPORT 2, AND MDR 1219913-2020-00119, SUPPLEMENTAL REPORT 2 WERE FILED FOR THE SAME EVENT.
SIEMENS FILED THE INITIAL MDR 1219913-2020-00118 REPORT ON (B)(6) 2020 FOR FALSE POSITIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS. (B)(6) 2020 . ADDITIONAL INFORMATION: B6: THE DATE OF TESTING FOR SIDS(B)(6) AND TOXO G REAGENT LOT 260 WAS (B)(6) 2020 AT APPROXIMATELY 10:00 AM. CORRECTION: H10: FOR THE 13 MONTHS OF PATIENT DATA AND TOXO G REAGENT LOTS REVIEWED BY SIEMENS. REAGENT LOT 258 WAS LISTED TWICE IN ERROR. THE CORRECTED LIST OF REAGENT LOTS REVIEWED WERE FOR LOTS 235, 239, 243, 245, 247, 249, 251, 252 AND 258. SIEMENS CONTINUES TO INVESTIGATE. MDR 1219913-2020-00113 SUPPLEMENTAL REPORT 1, MDR 1219913-2020-00114 SUPPLEMENTAL REPORT 1, MDR 1219913-2020-00117, AND MDR 1219913-2020-00119 SUPPLEMENTAL REPORT 1 WERE FILED FOR THE SAME EVENT.
SIEMENS FILED THE INITIAL MDR 1219913-2020-00118 REPORT ON 08-MAY-2020 FOR FALSE POSITIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS. MDR 1219913-2020-00118 SUPPLEMENTAL REPORT 1 WAS FILED ON 05-JUN-2020 FOR A CORRECTION AND ADDITIONAL INFORMATION. MDR 1219913-2020-00118 SUPPLEMENTAL REPORT 2 (FILED ON 27-JUL-2020) AND MDR 1219913-2020-00118 SUPPLEMENTAL REPORT 3 (FILED ON 13-OCT-2020) FOR ADDITIONAL INFORMATION. 27-SEP-2020 - ADDITIONAL INFORMATION: SIEMENS WAS INFORMED THAT THERE IS NOT ENOUGH SAMPLE AVAILABLE FOR HETEROPHILIC BLOCKING TUBE (HBT)/NON-SPECIFIC ANTIBODY TUBE (NABT) TESTING. SIEMENS CONTINUES TO INVESTIGATE. MDR 1219913-2020-00113 SUPPLEMENTAL REPORT 4, MDR 1219913-2020-00114 SUPPLEMENTAL REPORT 4, MDR 1219913-2020- 00117 SUPPLEMENTAL REPORT 4, AND MDR 1219913-2020-00119 SUPPLEMENTAL REPORT 4 WERE FILED FOR THE SAME PATIENT WITH DIFFERENT DATES OF TESTING.
SIEMENS FILED THE INITIAL MDR 1219913-2020-00118, REPORT ON (B)(6) 2020, FOR FALSE POSITIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS. MDR 1219913-2020-00118, SUPPLEMENTAL REPORT 1 WAS FILED ON (B)(6) 2020, FOR A CORRECTION AND ADDITIONAL INFORMATION. MDR 1219913-2020-00118, SUPPLEMENTAL REPORT 2 FILED ON (B)(6) 2020, MDR 1219913-2020-00118, SUPPLEMENTAL REPORT 3 (FILED ON 13-OCT-2020) AND MDR 1219913-2020-00118 SUPPLEMENTAL REPORT 4 FILED ON (B)(6) 2020 FOR ADDITIONAL INFORMATION. (B)(6) 2020 - ADDITIONAL INFORMATION: SIEMENS HAS CONCLUDED THE INVESTIGATION. THE CUSTOMER REPORTED FALSE REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS FROM A PATIENT WITH REAGENT LOT 258 VERSUS ALTERNATE METHODS. THE PATIENT SAMPLE HISTORICALLY HAD NONREACTIVE (NEGATIVE) RESULTS WHEN TESTED ON ATELLICA IM TOXO G REAGENT LOT 252. THE CUSTOMER OBSERVED A HIGH BIAS ON PATIENT SAMPLES WITH REACTIVE (POSITIVE) RESULTS WITH REAGENT LOT 258 VERSUS THE PREVIOUS REAGENT LOT OF 252. THE CUSTOMER'S CALIBRATIONS WERE DEEMED ACCEPTABLE AND SIEMENS QUALITY CONTROL RECOVERED WITHIN INSERT RANGES AND PEER DATA. THE CUSTOMER PERFORMED REAGENT LOT 258 TO REAGENT LOT 260 CORRELATIONS USING PATIENT AND EEQ (EXTERNAL QUALITY PROFICIENCY) SAMPLES. THE RESULT INTERPRETATIONS WERE OBSERVED TO BE SIMILAR. THERE WAS NOT SUFFICIENT VOLUME LEFT TO TREAT THE PATIENT SAMPLES WITH HETEROPHILIC BLOCKING TUBE (HBT) AND/OR NON-SPECIFIC ANTIBODY BLOCKING TUBES (NABT) OR TO BE SENT TO SIEMENS FOR FURTHER INVESTIGATION. THE ATELLICA IM TOXOPLASMA IGG (TOXO G) SIEMENS ANALYTICS SERVICE (SAS) PATIENT DATA WAS REVIEWED FROM (B)(6) 2019, TO (B)(6) 2020. REAGENT LOT 260 RECOVERED SIMILARLY WITH INTERPRETATION RATES OF PREVIOUS REAGENT LOTS 247, 249, 251, 252, AND 258. A REVIEW OF INTERNAL DATA FOR MEAN CONTROL RECOVERY COMPARING REAGENT LOTS 252 TO 258, AND REAGENT LOTS 258 TO 260, SHOWED THE SAME TREND; REAGENT LOT 258 ELEVATED COMPARED TO REAGENT LOTS 252 AND 260. FURTHER ANALYSIS OF THE SIEMENS INTERNAL DATA (GLOBAL AND FRANCE ONLY) FOR MEAN PATIENT RECOVERY ACROSS SEVERAL REAGENT LOTS, VERIFIED THAT REAGENT LOT 258 WAS ELEVATED COMPARED TO REAGENT LOTS 252 AND 260 GLOBALLY AND IN FRANCE. THE ATELLICA IM TOXOPLASMA IGG (TOXO G) INSTRUCTIONS FOR USE (IFU) 10995430_EN REV. (B)(6) 2019, INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "THE MAGNITUDE OF THE MEASURED RESULT ABOVE THE CUT-OFF VALUE IS NOT INDICATIVE OF THE TOTAL AMOUNT OF ANTIBODY PRESENT IN THE SAMPLE." SIEMENS INITIATED AN INTERNAL STUDY THAT INCLUDED TOXO G REAGENT LOTS 258, 260 AND 262, FIFTY (50) NORMAL PATIENT SAMPLES FROM SIEMENS AND FIFTY (50) PATIENT SAMPLES FROM FRANCE. THE PATIENT SAMPLES FROM FRANCE FOR THE INTERNAL STUDY WERE PURCHASED BY SIEMENS FROM AN APPROVED SUPPLIER AND FRENCH ACQUISITION COMPANY (INOSPECIMENS NIOBANK). ALL SAMPLES WERE TESTED IN REPLICATES OF 3 (N=3). THE FINAL INTERPRETATION WAS THE SAME FOR THE PATIENT SAMPLES ACROSS THE REAGENT LOTS, EXCEPT FOR ONE SIEMENS' SAMPLE THAT WAS NEAR THE CUTOFF OF 10 IU/ML. THE RECOVERY FOR THIS SAMPLE WAS WITHIN ACCEPTABLE PRECISION AT THAT LEVEL. BASED ON THE INFORMATION PROVIDED, THE CALCULATED SPECIFICITY FOR THIS CUSTOMER WITH REAGENT LOT 258 IS 395/396 = 0.9975 X100 = 99.75%. THE ATELLICA IM TOXOPLASMA IGG (TOXO G) INSTRUCTIONS FOR USE (IFU) INITIAL RELATIVE SPECIFICITY RESULTS FROM THE 3 STUDIES RANGE FROM 97.7%- 99.8%. THE ATELLICA IM TOXOPLASMA IGG REAGENT LOT 258 IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE ASSAY IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED. MDR 1219913-2020-00113, SUPPLEMENTAL REPORT 5, MDR 1219913-2020-00114, SUPPLEMENTAL REPORT 5, MDR 1219913-2020- 00117, SUPPLEMENTAL REPORT 5, AND MDR 1219913-2020-00119, SUPPLEMENTAL REPORT 5 WERE FILED FOR THE SAME PATIENT WITH DIFFERENT DATES OF TESTING.
SIEMENS FILED THE INITIAL MDR 1219913-2020-00118 REPORT ON 08-MAY-2020 FOR FALSE POSITIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS. MDR 1219913-2020-00118 SUPPLEMENTAL REPORT 1 WAS FILED ON 05-JUN-2020 FOR A CORRECTION AND ADDITIONAL INFORMATION. MDR 1219913-2020-00118 SUPPLEMENTAL REPORT 2 WAS FILED ON 27-JUL-2020 FOR ADDITIONAL INFORMATION. 26-SEP-2020 - ADDITIONAL INFORMATION: SIEMENS COMPLETED AN INTERNAL STUDY ON ATELLICA IM SYSTEM FOR TOXOPLASMA IGG (TOXO G) ASSAY. DURING THE STUDY TOXO G REAGENT LOTS 258, 260 AND 262 WERE USED. TOXO G REAGENT LOT 252 EXPIRED ON AUGUST 9TH, 2020 AND WAS RELABELED TO REAGENT LOT 997. RESULTS GENERATED WITH LOT 997 WERE SOLELY FOR INFORMATIONAL PURPOSES. FIFTY (50) NORMAL PATIENT SAMPLES FROM SIEMENS AND FIFTY (50) PATIENT SAMPLES FROM FRANCE WERE TESTED IN REPLICATES OF 3 (N=3). THE FINAL INTERPRETATION WAS THE SAME FOR ALL 50 SAMPLES FROM FRANCE AND FOR 49/50 PATIENT SAMPLES FROM SIEMENS. THE ONE SIEMENS NORMAL PATIENT SAMPLE WAS REACTIVE WITH REAGENT LOTS 997, 258 AND 260 AND EQUIVOCAL WITH REAGENT LOT 262. THIS IS A CUT OFF SAMPLE (10.0 IU/ML) AND RECOVERY WAS WITHIN ACCEPTABLE PRECISION AT THAT LEVEL. SIEMENS CONTINUES TO INVESTIGATE AND HAS REQUESTED HETEROPHILIC BLOCKING TUBE (HBT) AND NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) INFORMATION. IN SECTION H6, THE HEALTH EFFECT - CLINICAL CODE, CLINICAL IMPACT CODE AND THE COMPONENT CODE WERE ADDED. MDR 1219913-2020-00113 SUPPLEMENTAL REPORT 3, MDR 1219913-2020-00114 SUPPLEMENTAL REPORT 3, MDR 1219913-2020- 00117 SUPPLEMENTAL REPORT 3, AND MDR 1219913-2020-00119 SUPPLEMENTAL REPORT 3 WERE FILED FOR THE SAME EVENT.
THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT DISCORDANT, FALSE POSITIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) PATIENT RESULTS. SIEMENS HAS REVIEWED 13 MONTHS OF PATIENT DATA. THE DATA INCLUDED 338,073 RESULTS FROM 07-MAR-2019 TO 23-APR-2020 AND TOXO G REAGENT LOTS 235, 239, 243, 245, 247, 249, 251, 258 AND 258. THE RATE OF RESULT INTERPRETATIONS FOR REAGENT LOTS 252 AND 258 RECOVER SIMILAR AND COMPARABLE WITH THE OTHER REAGENT LOTS REVIEWED. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." THE INSTRUCTION FOR USE (IFU) STATES IN THE LIMITATIONS SECTION: "SPECIMENS COLLECTED IN THE EARLY STAGES OF INFECTION MAY HAVE IGG LEVELS THAT ARE CLASSIFIED AS NEGATIVE. IN GEOGRAPHIC REGIONS THAT HAVE AN APPARENT LOW PREVALENCE OF TOXOPLASMA IGG IN ASYMPTOMATIC POPULATIONS, THE POSITIVE PREDICTIVE VALUE OF ANY ASSAY IS REDUCED DUE TO THE INCREASED POSSIBILITY THAT A POSITIVE RESULT IS ACTUALLY FALSELY POSITIVE. AS WITH ALL IN VITRO DIAGNOSTIC ASSAYS, EACH LABORATORY SHOULD DETERMINE ITS OWN REFERENCE RANGE(S) FOR THE DIAGNOSTIC EVALUATION OF PATIENT RESULTS." MDR 1219913-2020-00113, MDR 1219913-2020-00114, MDR 1219913-2020-00117, AND MDR 1219913-2020-00119 WERE FILED FOR THE SAME EVENT.
FALSE POSITIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS WERE OBTAINED ON SAMPLES FROM THE SAME PATIENT TESTED WITH A NEW REAGENT TOXO G LOT (258). THE PREVIOUS TOXO G RESULTS FOR THIS PATIENT WERE NEGATIVE WHEN TESTED INITIALLY WITH REAGENT LOT (252). THE PATIENT SAMPLE WAS SENT TO A REFERENCE LABORATORY, TESTED ON AN ALTERNATE TOXO G METHOD, RESULTING NEGATIVE. THE FALSE POSITIVE TOXO G RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED ADDITIONAL TOXO G COMPARISON TESTING OF PATIENT SAMPLES WITH REAGENT LOT (260), RESULTING POSITIVE. THE SAME PATIENT SAMPLES WERE NEGATIVE WHEN TESTED AND COMPARED TO TE REFERENCE LABORATORY AND ALTERNATE TOXO G TEST METHOD. THE POSITIVE TOXO G COMPARISON RESULTS WITH REAGENT LOT 260 WERE NOT INTENDED FOR RELEASE TO THE PROVIDER(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT(S), FALSELY POSITIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 501328 | ATELLICA IM TOXOPLASMA IGG (TOXO G) | TOXOPLASMA GONDII IMMUNOASSAY | LGD | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | N/A | 258 | 00630414600123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |