BLOOD GROUPING REAGENT IH-CARD ABD(DVI+)-CONF
Report
- Report Number
- 9610824-2021-00086
- Event Type
- Malfunction
- Date Received
- January 24, 2022
- Date of Event
- December 30, 2021
- Report Date
- March 14, 2022
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- QHR
- UDI-DI
- 07611969952137
- PMA / PMN Number
- 125534
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS IS OUR INITIAL REPORT ON THIS INCIDENT.
THIS IS OUR FINAL REPORT ON THIS INCIDENT.
THE CUSTOMER REPORTED THAT EIGHT CONFIRMATION SAMPLES SHOWED FALSE POSITIVE RESULTS ON THE IH-CARD ABD(DVI+)-CONF WHEN USED ON THE IH-500. ALL SAMPLES CAME BACK AS BLOOD GROUP AB, BUT THE EXPECTED RESULTS WERE A POS, A NEG AND B POS. THE CUSTOMER STATED THAT FIVE OF THE EIGHT SAMPLES SHOWED CORRECT RESULTS WHEN RETESTED, WHILE THREE SAMPLES AGAIN SHOWED FALSE POSITIVE RESULTS. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE CONFIRMATION SAMPLES THAT CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE, OUR QUALITY CONTROL IS TESTING THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON IH-500. THIS TESTING IS STILL ONGOING. WE ARE ALSO STIL WAITING FOR THE SNAP SHOTS AND TRACE FILES OF THE AFFECTED IH-500 FOR INVESTIGATION. DUE TO THE ONGOING INVESTIGATION, WE ARE NOT IN THE POSITION TO PROVIDE A CONCLUSIVE STATEMENT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.
THE CUSTOMER REPORTED THAT EIGHT CONFIRMATION SAMPLES SHOWED FALSE POSITIVE RESULTS ON THE IH-CARD ABD(DVI+)-CONF WHEN USED ON THE IH-500. ALL SAMPLES CAME BACK AS BLOOD GROUP AB, BUT THE EXPECTED RESULTS WERE A POS, A NEG AND B POS. THE CUSTOMER STATED THAT FIVE OF THE EIGHT SAMPLES SHOWED CORRECT RESULTS WHEN RETESTED, WHILE THREE SAMPLES AGAIN SHOWED FALSE POSITIVE RESULTS. THE CUSTOMER PROVIDED IMAGES THAT CONFIRM HER CLAIM. THE CUSTOMER PROVIDED PRODUCT SAMPLES (26 IH-CARDS) FOR INVESTIGATIONAL TESTING AND ALSO EIGHT DONOR SAMPLES THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. WHILE OUR QUALITY CONTROL LABORATORY WAS WAITING FOR THE COMPLAINT MATERIAL OF THE CUSTOMER TO ARRIVE, THEY VISUALLY CHECKED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INTACT SEALING, HOMOGENEOUS GEL, VISIBLE SUPERNATANT, AND ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. ADDITIONALLY, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-500. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. ONCE THE PRODUCT OF SAMPLE RETURNED BY THE CUSTOMER ARRIVED ON OUR PREMISES, THE COMPLAINT SAMPLES WERE VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, VISIBLE SUPERNATANT, AND ABSENCE OF SPLASHES IN THE REACTION CHAMBER. THE SEALING WAS INTACT. BUT MOST OF THE CARDS SHOWED SPLASHES IN THE REACTION CHAMBER. NO SUPERNATANT WAS VISIBLE IN THESE CARDS. THESE CARDS WERE CENTRIFUGED BEFORE THEY WERE PROCESSED. THE DONOR SAMPLES PROVIDED BY THE CUSTOMER WERE TESTED WITH THE PRODUCT SAMPLE RETURNED BY THE CUSTOMER ON THE IH-500. DUE TO THE HEMOLYSIS OF THE SAMPLES, THE REACTIONS COULD NOT BE READ BY THE IH-500. BECAUSE OF THE VERY BAD STATUS OF THE DONOR SAMPLES NO FURTHER TESTS COULD BE PERFORMED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PRODUCT SAMPLES RETURNED BY THE CUSTOMER WITH DONOR SEGMENTS (SAME KIND OF SAMPLE MATERIAL CUSTOMER HAD USED) ON IH-500. THE TESTING WAS DONE IN PARALLEL WITH THEIR RETENTION SAMPLE. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. REGARDING THE AFFECTED IH-500 INSTRUMENT, THE DATA WERE CHECKED AND THE GEL CONTROL IMAGE OF THE CONCERNED IH-CARD (B)(4) COULD NOT BE FOUND. INSTEAD, OUR TECHNICAL SERVICE INVESTIGATED THE TWO IH CARDS NEAR TO THE MISSING BARCODE NUMBER. BOTH CARDS SHOWED DROPS IN THE INCUBATION CHAMBER. THIS COULD BE THE ROOT CAUSE OF THE INTER-WELLS CARRY-OVER. DUE TO THE OBSERVED SPLASHES IN THE REACTION CHAMBER, WE HIGHLY RECOMMEND THE CENTRIFUGATION OF THE CARDS BEFORE USE AS STATED IN THE IFU. GENERALLY, THE INTER-WELLS CONTAMINATION IS CAUSED BY USING IH-CARD ON BAD STATUS (DROPS OF ANTISERA UNDER THE ALUMINUM FOIL OF THE IH CARD) AND / OR THE NONCENTERING OF THE NEEDLE/ IH CARD WELLS. BASED ON THE ANALYSIS OF THE IMAGES OF THE IH-500 THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - EPP (EXPECTED PRODUCT PERFORMANCE). THE MOST PROBABLY ROOT CAUSE WAS AN INTERWELL CONTAMINATION CAUSED BY SPLASHES IN THE REACTION CHAMBER. THE COMPLAINT SAMPLE AND THE RETENTION SAMPLE REACTED AS EXPECTED. AS STATED IN THE RELEVANT SECTION OF THE IFU, THE COMPLAINT SAMPLE SHOULD HAVE BEEN CENTRIFUGED BEFORE USE DUE TO THE SPLASHES IN THE REACTION CHAMBER. BECAUSE OF THE SUSPECTED INTERWELL CONTAMINATION WE RECOMMEND TO THE CUSTOMER NOTING THE FOLLOWING POINTS ACCORDING TO THE CHAPTER "PRECAUTIONS" IN THE INSTRUCTION FOR USE: - DO NOT USE CARDS SHOWING SIGNS OF DRYING, DISCOLORATION, BUBBLES, CRYSTALS OR OTHER ARTIFACTS. · DO NOT USE CARDS WITH DAMAGED FOIL STRIPS. · DO NOT USE GEL CARDS IF THE GEL MATRIX IS ABSENT OR IF THE LIQUID LEVEL IN THE MICROTUBE IS NOT AT OR BELOW THE GEL MATRIX. A CLEAR LIQUID LAYER SHOULD BE VISIBLE ON TOP OF THE UNIFORM GEL MATRIX IN EACH MICROTUBE. · CARDS WITH DISPERSED DROPS OBSERVED AT THE TOP OF THE MICROTUBE, DUE TO IMPROPER STORAGE OR SHIPPING CONDITIONS, HAVE TO BE CENTRIFUGED WITH IH-CENTRIFUGE L OR IHREADER 24 WITH PRESET TIME AND SPEED BEFORE USE. IF DROPS ARE STILL OBSERVED ON TOP OF THE MICROTUBE AFTER ONE CENTRIFUGATION IT IS RECOMMENDED TO NOT USE THE CARD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1902021 | BLOOD GROUPING REAGENT IH-CARD ABD(DVI+)-CONF | IH-CARD ABD(DVI+)-CONF; 48 CARDS | QHR | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 9111010 | 07611969952137 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | IH-500, SN (B)(6).| IH-500, SN (B)(6). |