ADVIA CENTAUR XP TOXOPLASMA (TOXO M) ASSAY
Report
- Report Number
- 1219913-2017-00043
- Event Type
- Malfunction
- Date Received
- February 28, 2017
- Date of Event
- November 15, 2016
- Report Date
- August 7, 2017
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Product Code
- LGD
- PMA / PMN Number
- K010755
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE CAUSE FOR THE FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) PATIENT RESULT AND FOR THE OTHER TOXO M PATIENT RESULTS IS UNKNOWN. THE CUSTOMER'S TOXOPLASMA M (TOXO M) ASSAY CALIBRATION AND QUALITY CONTROL (QC) RESULTS ARE WITHIN ACCEPTABLE RANGES. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATIONS SECTION STTES THE FOLLOWING: "PATIENT SPECIMENS COLLECTED VERY EARLY DURING THE ACUTE PHASE OF INFECTION MAY CONTAIN TOXOPLASMA IGM LEVELS BELOW THE CUTOFF OF THE ADVIA CENTAUR TOXO M ASSAY. ADDITIONALLY, DIAGNOSIS OF A RECENT INFECTION SHOULD NOT BE MADE BASED ON A SINGLE SAMPLING BECAUSE IGM ANTIBODIES TO T. GONDII MAY PERSIST IN SERUM MANY MONTHS AFTER INFECTION. THE PRESENCE OF IGM ANTIBODIES TO T. GONDII IS NOT DIAGNOSTIC FOR RECENT INFECTION. BECAUSE TOXOPLASMA IGM MAY REMAIN IN SERUM FOR MANY MONTHS AFTER INFECTION, USE CAUTION IN INTERPRETING RESULTS FROM PATIENTS WHO MAY HAVE RECEIVED BLOOD TRANSFUSIONS OR INFUSION OF OTHER BLOOD PRODUCTS WITHIN THE PAST SEVERAL MONTHS. IN GEOGRAPHIC REGIONS THAT HAVE AN APPARENT LOW PREVALENCE OF TOXOPLASMA IGM 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." ADDITIONAL REAGENT LOT INFORMATION: LOT NO. 080269, 080270, 080272; EXPIRY DATE: 01/24/2017, 03/19/2017, 04/30/2017; UDI # (B)(4); DATE OF MANUFACTURE: 05/24/2016, 07/19/2016, 08/31/2016.
SIEMENS FILED THE INITIAL MDR 1219913-2017-00043 ON 02/28/2017 FOR FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) RESULTS ON PATIENT SAMPLES, MDR 1219913-2017-00043 SUPPLEMENTAL REPORT 1 ON 04/07/2017, AND MDR 1219913-2017-00043 SUPPLEMENTAL REPORT 2 OF 06/08/2017 FOR ADDITIONAL INFORMATION. 07/13/2017 - ADDITIONAL INFORMATION: THE CUSTOMER PROVIDED SIEMENS WITH 22 PATIENT SAMPLES FOR TESTING. OF THE SAMPLES TESTED, SIX (SIDS 1, 9, 10, 16, 17 AND 22) RECOVERED REACTIVE WITH THE IMMULITE 2000 TOXOPLASMA IGM ASSAY, AND ARE LIKELY TRUE POSITIVES AND ONE SAMPLE (SID 12) RECOVERED AS A HIGH NONREACTIVE WITH THE CENTAUR TOXOPLASMA IGM ASSAY. THE REMAINING FIFTEEN SAMPLES WERE TREATED WITH HETEROPHILIC BLOCKING TUBES (HBT). ALL FIFTEEN SAMPLES SHOWED A DECREASE IN INDEX AFTER HBT TREATMENT WHEN TESTED WITH THE CENTAUR TOXOPLASMA IGM ASSAY, HOWEVER ONE WAS STILL REACTIVE (SAMPLE 5) AND THREE OTHER SAMPLES WERE HIGH NON-REACTIVE (SIDS 11, 19, AND 21). THE RESULTS FOR THESE FOUR SAMPLES WERE INDETERMINATE WITH THE IMMULITE 2000 TOXOPLASMA IGM, AND UNKNOWN IF THESE SAMPLES HAVE A LOW LEVEL OF ANTIBODY AND/OR THERE IS SOMETHING INTERFERING WITH BOTH ASSAYS. FOR THE OTHER 11 SAMPLES (SID 2, 3, 4, 6, 7, 8, 13, 14, 15, 18, AND 20) THE DECREASE IN INDEX WITH THE CENTAUR TOXOPLASMA IGM ASSAY AFTER HBT TREATMENT, AND THE NON-REACTIVE IMMULITE 2000 TOXOPLASMA IGM RESULTS INDICATES HETEROPHILIC INTERFERENCE IS ELEVATING THE RESULTS WITH THE CENTAUR TOXOPLASMA IGM ASSAY. BASED ON THE AVAILABLE INFORMATION THE CENTAUR TOXOPLASMA IGM ASSAY IS PERFORMING AS INTENDED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. CUSTOMER TEST RESULTS: SID: PID: INTERPRETATION: ADVIA CENTAUR: REAGENT LOT: REFERENCE LAB: METHOD: SAMPLE 12 (30414029), EQUIVOCAL, 0.9, 272, 0.16, EIA; SAMPLE 1 (12050821), REACTIVE, 2.15, 268, 0.33, EIA; SAMPLE 9 (30101017), REACTIVE, 1.6, 272, 0.22, EIA; SAMPLE 10 (30216207), REACTIVE, 2.77, 272, 0.27, EIA; SAMPLE 16 (32505043), REACTIVE, 1.55, 272, 0.9, EIA; SAMPLE 17 (31508129), REACTIVE, 1.96, 272, 0.22, EIA; SAMPLE 22 (32913002), REACTIVE, 1.16, 268, 0.47, ELFA; SAMPLE 5 (21508130), REACTIVE, 1.94, 272, 0.34, ELFA; SAMPLE 11 (30400116), REACTIVE, 1.53, 272, 0.18, EIA; SAMPLE 21 (41108073), REACTIVE, 1.39, 274, 0.22, ELFA; SAMPLE 19 (41000097), REACTIVE, 1.45, 274, 0.3, ELFA; SAMPLE 18 (40405015), REACTIVE, 1.86, 272, 0.52, ELFA; SAMPLE 7 (22108100), REACTIVE, 1.21, 272, 0.23, EIA; SAMPLE 4 (21503054), REACTIVE, 1.12, 272, 0.65, EIA; SAMPLE 13 (30603149), EQUIVOCAL, 0.98, 272, 0.1, EIA; SAMPLE 2 (21003106), REACTIVE, 2.97, 272, 0.4, EIA; SAMPLE 14 (30801099), EQUIVOCAL, 0.97, 272, 0.8, EIA; SAMPLE 20 (40103108), REACTIVE, 1.16, 274, 0.47, ELFA; SAMPLE 8 (30104012), REACTIVE, 1.77, 272, 0.13, EIA; SAMPLE 6 (21705037), REACTIVE, 1.52, 272, 0.52, EIA, SAMPLE 3 (10603085), REACTIVE, 1.03, 268, 0.25, EIA; SIEMENS RETURN SAMPLE TESTING: ADVIA CENTAUR XP: ADVIA CENTAUR XP: IMMULITE 2000XPI: LOT: 278, LOT 278, LOT 220, SID : PID: RESULT (NEAT): RESULT (HBT): RESULT (NEAT): SAMPLE 12 (30414029), 0.89 NON-REACTIVE; - SAMPLE 1 (12050821), 2.2 REACTIVE, 1.1 REACTIVE' SAMPLE 9 (30104017), 2.0 REACTIVE, 1.2 REACTIVE; SAMPLE 10 (30216207), 3.3 REACTIVE, 1.4 REACTIVE; SAMPLE 16 (32505043), 2.1 REACTIVE, 1.2 REACTIVE; SAMPLE 17 (31508129), 2.1 REACTIVE, 1.2 REACTIVE; SAMPLE 22 (32913002), 1.9 REACTIVE, 1.1 REACTIVE; SAMPLE 5 (21508130), 2.1 REACTIVE, 1.2 REACTIVE, 0.9 INDETERMINATE; SAMPLE 11 (30400116), 1.7 REACTIVE, 0.86 NON-REACTIV,E 0.9 INDETERMINATE; SAMPLE 21 (41108073), 1.6 REACTIVE, 0.82 NON-REACTIVE, 1.0 INDETERMINATE; SAMPLE 19 (41000097), 1.7 REACTIVE, 0.79 NON-REACTIVE, 1.0 INDETERMINATE; SAMPLE 18 (40405015), 2.8 REACTIVE, 0.29 NON-REACTIVE, 0.9 INDETERMINATE; SAMPLE 7 (22108100), 1.5 REACTIVE, 0.53 NON-REACTIVE, 0.8 NON-REACTIVE; SAMPLE 4 (21503054), 1.4 REACTIVE, 0.48 NON-REACTIVE, 0.8 NON-REACTIVE; SAMPLE 13 (30603149), 1.6 REACTIVE, 0.43 NON-REACTIVE, 0.7 NON-REACTIVE; SAMPLE 15 (31005029), 1.1 REACTIVE, 0.35 NON-REACTIVE, 0.6 NON-REACTIVE; SAMPLE 2 (21003106), 2.5 REACTIVE, 0.35 NON-REACTIVE, 0.6 NON-REACTIVE; SAMPLE 14 (30801099), 1.1 REACTIVE, 0.27 NON-REACTIVE, 0.3 NON-REACTIVE; SAMPLE 20 (40103108), 1.7 REACTIVE, 0.22 NON-REACTIVE, 0.7 NON-REACTIVE; SAMPLE 8 (30104012), 1.5 REACTIVE, 0.22 NON-REACTIVE, 0.5 NON-REACTIVE; SAMPLE 6 (21705037), 1.3 REACTIVE, 0.16 NON-REACTIVE, 0.6 NON-REACTIVE; SAMPLE 3 (10603085), 1.0 REACTIVE, 0.13 NON-REACTIVE, 0.4 NON-REACTIVE.
SIEMENS FILED THE INITIAL MDR 1219913-2017-00043 ON 02/28/2017 FOR FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) RESULTS ON PATIENT SAMPLES, AND MDR 1219913-2017-00043 SUPPLEMENTAL REPORT 1 ON 04/07/2017 FOR ADDITIONAL INFORMATION. ON 05/15/17 - ADDITIONAL INFORMATION: BASED ON THE INFORMATION PROVIDED, THE CAUSE FOR THE FALSE POSITIVE ADVIA CENTAUR XP TOXO M PATIENT RESULTS IS UNKNOWN. THE NUMBER OF NEGATIVE SAMPLES THE CUSTOMER HAS TESTED WITH THE ADVIA CENTAUR XP TOXO M REAGENT LOT 268 IS 834, AND (8) POSITIVES. BASED ON THIS INFORMATION, THE CALCULATED RELATIVE SPECIFICITY WITH REAGENT LOT NUMBER (268) IS 99% (834/842). FOR REAGENT LOT 272, DUE TO A LIMITED NUMBER OF NEGATIVE SAMPLES TESTED BY THE CUSTOMER, RELATIVE SPECIFICITY COULD NOT BE DETERMINED. THERE HAS BEEN NO OTHER REPORTED ADVIA CENTAUR XP FALSE POSITIVE TOXO G COMPLAINTS FOR REAGENT LOT 272. BASED ON THE AVAILABLE INFORMATION, THE ADVIA CENTAUR XP TOXO M ASSAY IS PERFORMING AS INTENDED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
SIEMENS FILED THE INITIAL MDR 1219913-2017-00043 ON 02/28/2017 FOR FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) RESULTS ON PATIENT SAMPLES. ON 03/22/17 - ADDITIONAL INFORMATION: SIEMENS HAS RECEIVED FURTHER INFORMATION ON FOUR OF THE ORIGINALLY REPORTED PATIENT RESULTS, AND NEW DISCORDANT PATIENT RESULTS. THE PATIENT SAMPLES WERE TESTED AT TWO OTHER ALTERNATE LABORATORIES WITH ADVIA CENTAUR SYSTEMS, AND THE RESULTS WERE CONSIDERED TO BE FALSE REACTIVE FOR TOXO M. SIEMENS CONTINUES TO INVESTIGATE. CUSTOMER FACILITY: (B)(6) 2016 (B)(6) LOT 268 6.03 (REACTIVE); (B)(6) 2017 (B)(6) LOT 272 N/A - (REPORTED IN INITIAL MDR); (B)(6) 2017 (B)(6) LOT 272 N/A - (REPORTED IN INITIAL MDR); (B)(6) 2016 (B)(6) LOT 268 N/A - (REPORTED IN INITIAL MDR). ALTERNATE LABORATORY ((B)(6)) DATE: (B)(6) 2017, REAGENT LOT 272: (B)(6) 6.74 (REACTIVE); (B)(6) 2.29 (REACTIVE); (B)(6) 1.94 (REACTIVE); (B)(6) 0.99 (INDETERMINATE). ALTERNATE LABORATORY ((B)(6)) DATE: (B)(6)(B)(6) 2017, REAGENT LOT 272: (B)(6) 6.24 (REACTIVE), (B)(6) 2.05 (REACTIVE), (B)(6) 1.69 (REACTIVE), (B)(6) 0.97 (INDETERMINATE). NEW PATIENT RESULTS: CUSTOMER FACILITY: (B)(6) 2017 (B)(6) LOT 268 0.98 (INDETERMINATE), (B)(6) 2017 (B)(6) LOT 268 1.03 (REACTIVE), (B)(6) 2016 (B)(6) LOT 268 2.15 (REACTIVE), (B)(6) 2017 (B)(6) LOT 268 2.35 (REACTIVE), (B)(6) 2016 (B)(6) LOT 268 2.56 (REACTIVE), (B)(6) 2016 (B)(6) LOT 268 6.48 (REACTIVE), (B)(6) 2017 (B)(6) LOT 272 2.65 (REACTIVE), (B)(6) 2016 (B)(6) LOT 272 1.01 (REACTIVE). ALTERNATE LABORATORY ((B)(6)) DATE: (B)(6) 2017, REAGENT LOT 272: (B)(6) 1.06 (REACTIVE), (B)(6) 1.05 (REACTIVE), (B)(6) 2.19 (REACTIVE), (B)(6) 2.6 (REACTIVE), (B)(6) 2.79 (REACTIVE), (B)(6) 6.79 (REACTIVE), (B)(6) 2.73 (REACTIVE), (B)(6) 1.04 (REACTIVE). ALTERNATE LABORATORY ((B)(6)) DATE: (B)(6) 2017, REAGENT LOT 272: (B)(6) 1.06 (REACTIVE), (B)(6) 1.05 (REACTIVE), (B)(6) 2.17 (REACTIVE), (B)(6) 2.37 (REACTIVE), (B)(6) 2.65 (REACTIVE), (B)(6) 7.04 (REACTIVE), (B)(6) 2.42 (REACTIVE), (B)(6) 1.12 (REACTIVE).
A FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) RESULT WAS OBSERVED BY THE CUSTOMER ON A PATIENT SAMPLE. THE PATIENT WAS REDRAWN AT A LATER DATE, AND THE ADVIA CENTAUR XP TOXO M RESULT WAS POSITIVE. AT THE REQUEST OF THE ATTENDING PHYSICIAN, THE REDRAWN SAMPLE WAS TESTED AT A REFERENCE LABORATORY ON AN ALTERNATE TOXOPLASMA M TEST METHOD, AND THE RESULT WAS NEGATIVE. THE PATIENT WAS DRAWN A THIRD TIME, THE ADVIA CENTAUR XP TOXO M RESULT WAS POSITIVE, AND THE REFERENCE LABORATORY ALTERNATE TOXOPLASMA M TEST METHOD RESULT WAS NEGATIVE. A CORRECTIVE REPORT WAS ISSUED BY THE CUSTOMER. THE CUSTOMER HAS ALSO OBSERVED OTHER POSITIVE ADVIA CENTAUR XP TOXO M PATIENT RESULTS THAT WERE NOT CONFIRMED WITH AN ALTERNATE TOXOPLASMA M TEST METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE RESULTS ON THE ADVIA CENTAUR XP TOXO M ASSAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148342 | ADVIA CENTAUR XP TOXOPLASMA (TOXO M) ASSAY | TOXO M IMMUNOASSAY | LGD | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | N/A | 080268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |