MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-CELL I-II-III; IH-CELL I-II-III; 3X10 ML (REAGENT RED BLOOD CELLS FORMULATED FOR USE IN AUTOMAT

Catalog Number	814030100
Health Effect - Clinical Code	Reaction (2414)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false negative reactions of one patient sample when tested with ih-cell i-ii-iii on ih-1000.The customer stated that the customer had a known anti-e and anti-lu(a).The customer returned neither the complaint sample ih-cell i-ii-iii for investigational testing nor the patient sample that had caused false negatives, but agreed to forward the trace files of the ih-1000.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot ih-cell i-ii-iii with different controls and samples on ih-1000, e.G.Anti-e and anti-lu(a).All positive and negative reactions were correct.We did not observe any false negative reaction.We are still waiting for the trace files of the ih-1000 for investigation.Testing by our quality control laboratory confirmed that the allegedly defective lot of ih-cell i-ii-iii functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Event or Problem Description
The customer reported false negative reactions of one patient sample when tested with ih-cell i-ii-iii on ih-1000.The customer stated that the customer had a known anti-e and anti-lu(a).The customer returned neither the complaint sample ih-cell i-ii-iii for investigational testing nor the patient sample that had caused false negatives, but forwarded the trace files of the ih-1000.Our quality control laboratory tested their retention sample of the supposedly defective lot of ih-cell i-ii-iii with different controls and samples on ih-1000, e.G.Anti-e and anti-lu(a).All positive and negative reactions were correct.We did not observe any false negative reaction.The trace files were reviewed.The outcome of the investigation was a confirmation that the antibody screening test results were clearly negative on the both dates.But based on the panel results, the reaction was not compatible with anti-e and anti-lu(a), however it was for anti-c.Because the affected sample was no more available for further investigation and testing, this discrepancy could not be solved.But we could not identify any instrument malfunction.Testing by our quality control laboratory confirmed that the allegedly defective lot of ih-cell i-ii-iii functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The investigation of the trace files showed no malfunction of the instrument.The false negative result at the customer´s site remains unknown.We did not receive any further complaints related to this issue.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLS IH-CELL I-II-III
• Common Device Name: IH-CELL I-II-III; 3X10 ML (REAGENT RED BLOOD CELLS FORMULATED FOR USE IN AUTOMAT
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 9990088
• Report Number: 9610824-2020-00020
• Device Sequence Number: 16932993
• Product Code: QHT
• UDI-Device Identifier: 07611969952267
• UDI-Public: (01)07611969952267(17)200406(10)8007011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2020
• Device Catalogue Number: 814030100
• Device Lot Number: 8007011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IH-1000, SN (B)(6) ; IH-1000, SN (B)(6) ; IH-CARD AHG ANTI-IGG, LOT 8910020; IH-CARD AHG ANTI-IGG, LOT 8910020; IH-PANEL 11, LOT 8007011; IH-PANEL 11, LOT 8007011