REAGENT RED BLOOD CELLS IH-CELL A1 & B
Report
- Report Number
- 9610824-2019-00071
- Event Type
- Malfunction
- Date Received
- November 20, 2019
- Date of Event
- November 4, 2019
- Report Date
- January 5, 2021
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- QHT
- UDI-DI
- 07611969952243
- PMA / PMN Number
- 125208
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS IS OUR FINAL REPORT ON THIS INCIDENT.
THE CUSTOMER REPORTED DISCREPANT RESULTS IN REVERSE TYPING ON IH-1000. THE CUSTOMER USED IH-CELL A1&B AND IH-CARD ABO/D(DVI+)+REV A1,B (LOT NO. 8912020) AND IH-CARD ABO/D(DVI-)+REV A1, B (LOT NO. 8920030). THE CUSTOMER STATED THAT ONE OF THE WELLS OF THE BACK TYPE HAD NO REACTION WHEN A POSITIVE REACTION WAS EXPECTED. FURTHERMORE, THE CUSTOMER STATED THAT THE REACTIONS WERE CORRECTLY POSITIVE IN THE TUBE TEST. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER PROVIDED SCREEN PRINTS OF SIX (6) SAMPLES THAT CONFIRMED THE FALSE NEGATIVE REACTIONS IN REVERSE TYPING ON IH-1000 BUT NO FURTHER INFORMATION ABOUT THE PATIENT CLINICAL DETAILS. HOWEVER, THE CUSTOMER PROVIDED THESE 6 SAMPLES TESTED BETWEEN (B)(6) 2019 USING THE PREVIOUSLY MENTIONED PRODUCTS. REVIEW OF THE FILES FOR 1 OF THE SAMPLES INDICATED THERE WERE NO INSTRUMENT ERRORS NOTED DURING THE TESTING. CORRECT VOLUMES OF SAMPLE AND IH-CELL A1&B WERE DISPENSED INTO THE WELLS. HOWEVER, FILES WERE NOT AVAILABLE FOR THE REMAINING 5 SAMPLES. THE 6 SAMPLES WERE TESTED WITH IH-CELL A1&B, LOT 8939011, 8943011 AND REVERSE GROUP CELLS FROM ANOTHER MANUFACTURER. THE NEGATIVE RESULTS SEEN AT THE CUSTOMER FACILITY COULD BE REPRODUCED BY OUR PRODUCT SUPPORT. WE ASSUME THAT THE NEGATIVE REVERSE CELL GROUPING RESULTS ARE PATIENT RELATED. IT IS SCIENTIFICALLY PROVEN THAT SOME PATIENTS CAN SHOW A LACK OF ABO ANTIBODIES ESPECIALLY IN OLDER AGE OR WHEN A DIET OF HIGHLY PROCESSED FOODS IS CONSUMED. THE SECTION LIMITATION OF THE INSTRUCTION FOR USE CONTAINS AN APPROPRIATE NOTE: "DECREASED OR MISSING ABO ANTIBODY REACTIVITY MAY BE SEEN IN DISEASE STATES, THE ELDERLY OR INFANTS RESULTING IN FALSE NEGATIVE REACTIONS." A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. AS THE INSTRUCTION FOR USE ALREADY CONTAINS AN APPROPRIATE NOTE, NO FURTHER INVESTIGATIONS OR ACTIONS WERE INITIATED.
THIS IS OUR INITIAL REPORT ON THIS INCIDENT.
THE CUSTOMER REPORTED DISCREPANT RESULTS IN REVERSE TYPING ON IH-1000. THE CUSTOMER USED IH-CELL A1&B AND IH-CARD ABO/D(DVI+)+REV.A1,B AND IH-CARD ABO/D(DVI-)+REV.A1, B FOR HIS TESTING. HE PROVIDED SCREEN PRINTS OF SIX SAMPLES THAT HAD CAUSED FALSE NEGATIVE REACTIONS IN REVERSE TYPING ON IH-1000. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER ANNOUNCED TO SEND IN SAMPLES FOR INVESTIGATIONAL TESTING AND WE ARE AWAITING THESE SAMPLES. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1146010 | REAGENT RED BLOOD CELLS IH-CELL A1 & B | IH-CELL A1 & B; 2X10 ML | QHT | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 8939011 | 07611969952243 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IH CARD ABO RH DVI+, LOT 8912020| IH CARD ABO RH DVI+, LOT 8912020| IH CARD ABO RH DVI-, LOT 8920030| IH CARD ABO RH DVI-, LOT 8920030| IH-1000, NS 5100056| IH-1000, NS 5100056 |