BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND SOLIDSCREEN II
Report
- Report Number
- 9610824-2020-00034
- Event Type
- Malfunction
- Date Received
- June 19, 2020
- Date of Event
- April 8, 2020
- Report Date
- September 28, 2020
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- QHR
- UDI-DI
- 07611969951512
- PMA / PMN Number
- 125218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS IS OUR FINAL REPORT ON THIS INCIDENT.
THE CUSTOMER REPORTED ABOUT FALSE NEGATIVE RESULT FOR WEAK D: TESTED AS INDETERMINATE FOR RHD ON THEIR PK ANALYZER AND WEAK D NEGATIVE ON THE TANGO INFINITY ON TWO DONORS. GENOMIC TESTING SHOWED THEM TO BE WEAK D VARIANTS. AS PART OF INVESTIGATION FOR REPORT NO 9610824-2020-00032, THE CUSTOMER MENTIONED TWO OTHER OCCASIONS WHERE A DONOR TESTED AS INDETERMINATE FOR RHD ON THEIR PK ANALYZER AND WEAK D NEGATIVE ON THE TANGO INFINITY. SUBMITTING DONOR CENTERS REPORTED THAT GENOMIC TESTING ON THESE DONORS SHOWED THEM TO BE WEAK D VARIANTS. THE CUSTOMER DID NOT HAVE SAMPLES OR ACTUAL REPORTS REGARDING THE TYPE OF WEAK D THE GENOMIC TESTING RESULTED. THE CUSTOMER COULD NOT PROVIDE RESULT IMAGES OF ORIGINAL TESTING DUE TO LENGTH OF TIME SINCE THE INSTANCES HAPPENED. THE LAST PREVENTATIVE MAINTENANCE ON THE AFFECTED TANGO INFINITY WAS CONDUCTED ON JANUARY 15, 2020. AFTER THE CUSTOMER FILED HIS COMPLAINT, A FIELD SERVICE ENGINEER CHECKED THE AFFECTED INSTRUMENT. THE ENGINEER WAS ON SITE TO COLLECT DATA AND VERIFY CAMERA SETTINGS. THE INSTRUMENT WAS CONFIRMED TO OPERATE WITHIN SPECIFICATIONS. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES. THE WEAK D POSITIVE CONTROL REACTED MAINLY AS STRONG POSITIVE. THE CUSTOMER RETURNED THE SOLIDSCREEN II ANTI-D BLEND (REF #806530100, LOT #8913230-01), THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II (REF #806516100, LOT #8906080-05) AND SIX TUBES OF THE PATIENT SAMPLE #(B)(6) FOR INVESTIGATIONAL TESTING. THE CUSTOMER STATED THAT TWO TUBES EACH WERE PROCESSED ON TANGO INFINITY, THE PK INSTRUMENT AND THE PRISM INSTRUMENT. THE SAMPLES PROVIDED BY THE CUSTOMER WERE LABELED AS PK, TANGO AND PRISM. WE WOULD LIKE TO POINT OUT THAT THE SAMPLES LABELED AS TANGO AND PRISM WERE NATIVE SAMPLES AND THEREFORE NOT SUITED FOR BEING PROCESSED ON THE TANGO INSTRUMENT. OUR QUALITY CONTROL LABORATORY ONLY TESTED THE SAMPLE LABELED AS PK IN THE WEAK D ASSAY ON TANGO INFINITY AND YIELDED A STRONGLY POSITIVE RESULT. PRIOR TO TESTING THE "PK SAMPLE" WAS WASHED FIVE TIMES WITH ISOTONIC SALINE DUE TO HEMOLYSIS. ADDITIONALLY THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II PROVIDED BY THE CUSTOMER WAS TESTED FOR POTENCY. THE REAGENT WAS TESTED IN PARALLEL WITH OUR QC LAB'S RETENTION SAMPLE AND A REFERENCE LOT. ALL THREE AHG REAGENTS MET THE ACCEPTANCE CRITERIA AND SHOWED COMPARABLE RESULTS. FURTHERMORE THE COMPLAINT SAMPLE SOLIDSCREEN II ANTI-D BLEND WAS TESTED FOR SPECIFICITY ON TANGO INFINITY. THE POSITIVE SPECIFICITY WAS VERIFIED WITH THREE DIFFERENT SAMPLES (WEAK D TYPE 1, WEAK D TYPE 2 AND WEAK D TYPE 3). THIS TESTING WAS CONDUCTED IN PARALLEL WITH THE RETENTION SAMPLE AND A REFERENCE LOT ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. BASED ON AVAILABLE INFORMATION THERE IS NO INDICATION FOR AN INSTRUMENT MALFUNCTION. THE SERVICE ENGINEER CONFIRMED A PROPER FUNCTION OF THE INSTRUMENT. FROM REAGENT´S PERSPECTIVE THE CORRECT FUNCTION OF THE COMPLAINT SAMPLE AS WELL AS THE RETENTION SAMPLE COULD BE CONFIRMED. THE PROVIDED PATIENT SAMPLE YIELDED A CORRECTLY POSITIVE RESULT WITH THE REAGENTS PROVIDED BY CUSTOMER. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE WOULD LIKE TO POINT OUT THAT NATIVE (CLOTTED) SAMPLES ARE NOT SUITED FOR THE WEAK D TESTING ON TANGO INSTRUMENT. THE USE OF A NATIVE SAMPLE MIGHT BE THE CAUSE OF THE FALSE NEGATIVE RESULTS AT CUSTOMER´S SITE.
THIS IS OUR INITIAL REPORT ON THIS INCIDENT.
THE CUSTOMER REPORTED ABOUT FALSE NEGATIVE RESULT FOR WEAK D: TESTED AS INDETERMINATE FOR RHD ON THEIR PK ANALYZER AND WEAK D NEGATIVE ON THE TANGO INFINITY ON TWO DONORS. GENOMIC TESTING SHOWED THEM TO BE WEAK D VARIANTS. THE CUSTOMER COULD NOT PROVIDE RESULT IMAGES OF ORIGINAL TESTING DUE TO LENGTH OF TIME SINCE THE INSTANCES HAPPENED. THE LAST PREVENTATIVE MAINTENANCE ON THE AFFECTED TANGO INFINITY WAS CONDUCTED ON (B)(6) 2020. AFTER THE CUSTOMER FILED HIS COMPLAINT, A FIELD SERVICE ENGINEER CHECKED THE AFFECTED INSTRUMENT. THE ENGINEER WAS ON SITE TO COLLECT DATA AND VERIFY CAMERA SETTINGS. THE INSTRUMENT WAS CONFIRMED TO OPERATE WITHIN SPECIFICATIONS. THE LOG FILES ANALYSIS IS STILL ON-GOING. THE CUSTOMER RETURNED THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II (REF #(B)(4), LOT #8906080-05), BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT SOLIDSCREEN II ANTI-D BLEND (REF # (B)(4), LOT #8848040-01). THEREFORE OUR QUALITY CONTROL LABORATORY STARTED TESTING THEIR RETENTION SAMPLE OF SOLIDSCREEN II ANTI-D BLEND AND THE AHG PROVIDED BY CUSTOMER ON TANGO INFINITY. THIS TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. 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 |
|---|---|---|---|---|---|---|---|
| 636192 | BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND SOLIDSCREEN II | SOLIDSCREEN II ANTI-D BLEND, 5ML | QHR | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 8913230-01 | 07611969951512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AHG, LOT 8906080-05| AHG, LOT 8906080-05| ALSEVERS, LOT 8916100-00| ALSEVERS, LOT 8916100-00| SOLIDSCREEN II STRIP, LOT 8935040| SOLIDSCREEN II STRIP, LOT 8935040| TANGO INFINITY, # 4230000155| TANGO INFINITY, # 4230000155 |