MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL A2; BIOTESTCELL 2

Catalog Number 816047100

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

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

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a weak false positive reaction of biotestcell-a2 with the anti-a1 lectin reagent of a competitor.The customer provided a sample of the allegedly defective product biotestcell-a2 for investigational testing and also the anti-a1 reagent.Our quality control laboratory tested the complaint sample as well as their retention sample of biotestcell a2 with the anti-a1 lectin reagent and could confirm the customer´s finding: the supposedly defective product yielded a weak false positive reaction.Additionally the complaint and the retention sample of biotestcell-a2 were tested with seraclone anti-a1 and yielded correctly negative reactions.The weak false positive reactions were only observed with the anti-a1 lectin reagent of a competitor.Based on this false positive reaction we initiated further actions.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 BIOTESTCELL A2
• Type of Device: BIOTESTCELL 2
• 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: 8563627
• MDR Text Key: 203367411
• Report Number: 9610824-2019-00021
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952625
• UDI-Public: (01)07611969952625(17)190408(10)8907011-00
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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: 816047100
• Device Lot Number: 89007011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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