MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-CELL A1 & B; IH-CELL A1 & B; 2X10 ML

Catalog Number 814010100

Device Problems False Positive Result (1227); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

This is our combined initial and final report on this incident.

Event Description

The customer reported false positive reactions of two patient samples with cell b of ih-cell a1&b on ih-1000.The customer stated that both patients were typed as blood group b.Therefore the reverse type did not match the front type.Due to the discrepancy between forward and reverse typing, the ih-1000 stated "abo not interpretable" and no incorrect results were released.The customer did not return the supposedly defective product for investigational testing, but one patient sample that had caused a false positive test result.Due to the small quantity of the provided patient sample it could not be tested on ih-1000.Therefore our quality control laboratory tested different donor samples with the retention sample of ih-cell a1&b on ih-1000.All positive and negative reactions were correct.We did not observe any false positive reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of ih-cell a1&b functions correctly.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.

• Brand Name: REAGENT RED BLOOD CELLS IH-CELL A1 & B
• Type of Device: IH-CELL A1 & B; 2X10 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8503212
• MDR Text Key: 152514637
• Report Number: 9610824-2019-00016
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952243
• UDI-Public: (01)07611969952243(17)190408(10)8907011
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2019
• Device Catalogue Number: 814010100
• Device Lot Number: 8907011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1