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

Catalog Number	816021100
Health Effect - Clinical Code	Test Result (2695)
Date of Event	08/04/2020
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 a false negative reaction of cell #1 (donor #: (b)(6)) of biotestcell-i11 with the anti-le(b) reagent of a competitor.According to the antigen worksheet cell #1 is lea-b+.The customer stated that she used cell #1 as a positive control for the anti-le(b) reagent of the competitor.The customer stated that cell #2 (donor (b)(6)) of biotestcell 1&2, which is also le(b) positive yielded a correct positive result.The customer returned the complaint sample biotestcell-i11 for investigational testing but not the anti-le(b) reagent of the competitor.At the time we received the complaint sample the supposedly defective product was already expired.Nevertheless our quality control laboratory tested the complaint sample with seraclone anti-le(b).The test was performed manually in the tube technique with an incubation of 15 minutes at room temperature according to the instruction for use of seraclone anti-le(b).Cell #1 of biotestcell-i11 yielded a correct positive result.We did not observe any false negative result.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotestcell-i11 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.We did not receive any further complaints related to this issue.

• 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: 10475479
• Report Number: 9610824-2020-00054
• Device Sequence Number: 3557987
• Product Code: QHT
• UDI-Device Identifier: 07611969952434
• UDI-Public: (01)07611969952434(17)200817(10)8025021-00
• 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
• Report Date (Section B): 09/01/2020

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: 08/17/2020
• Device Catalogue Number: 816021100
• Device Lot Number: 8025021-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1