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	03/18/2019
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 a false negative reaction of cell #10 of the product biotestcell-i11.The customer stated that cell #10 was tested manually with seraclone anti-m and yielded into negative test reactions instead of positive test reactions.The customer provided neither the supposedly defective product biotestcell-i11 nor the involved seraclone anti-m reagent.Therefore our quality control laboratory tested the retention sample of this biotestcell-i11 lot manually with seraclone anti-m.Cell #10 of biotestcell-i11 showed a correctly positive result.Testing by the quality control laboratory confirmed the correct function of the allegedly defective lot of biotestcell-i11.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of both allegedly defective lots.No instruments were involved because of a manually test procedure.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL-I11
• Common Device Name: BIOTESTCELL-I11
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8513730
• Report Number: 9610824-2019-00017
• Device Sequence Number: 2798250
• Product Code: KSZ
• UDI-Device Identifier: 07611969952434
• UDI-Public: (01)07611969952434(17)190325(10)8905011-00
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/15/2019

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: 03/25/2019
• Device Catalogue Number: 816021100
• Device Lot Number: 8905011-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1