MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL-I11

Catalog Number	816021100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported false negative result of cell #4 of biotestcell-i11 with anti-le(b) reagents.Because cell #4 (donor no.103355) is listed as le(b) positive in the antigen profile worksheet, the customer assumed that this was likely a printing error on the worksheet.The customer returned neither the supposedly defective product for investigational testing nor the anti-le(b) reagents.Therefore our quality control laboratory tested cell #4 of their biotestcell-i11 retention sample with the blood grouping reagent seraclone anti-le(b) and got only a +/- reaction.This is a questionable result and not a clear positive reaction.Further tests confirmed that the sample of cell #4 does not always give clearly positive results with anti-le(b) reagents.Based on the test results the complaint was confirmed.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.But based on the confirmed complaint a deviation was initiated and the donor was blocked.No further similar complaints have been reported.There is no risk for patients.Anti-le(b) antibodies belong to the group of igm's, are therefore not clinically relevant and do not lead to hemolytic transfusion reactions.Igm antibodies are not placental and do not damage the fetus or lead to mhn (morbus hämolyticus-neonatorum) in the newborn.Because other cells in biotestcell- i11 are le(b) positive, an anti-le(b) will be detected but detection might be delayed because of the unexpected negative reaction in cell #4.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL-I11
• Common Device Name: BIOTESTCELL-I11
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 9415237
• Report Number: 9610824-2019-00078
• Device Sequence Number: 2791561
• Product Code: KSZ
• UDI-Device Identifier: 07611969952434
• UDI-Public: (01)07611969952434(17)191202(10)8941011-00
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: 12/02/2019
• Device Catalogue Number: 816021100
• Device Lot Number: 8941011-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1