MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-M (MNS1); 2ML; SERACLONE ANTI-N (MNS1)

Catalog Number 808410

Device Problem False Positive Result (1227)

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

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a false positive reaction of a patient sample with seraclone anti-m.And asked whether there might be a cross-reaction of the patient sample which is mns6 (henshaw, he) positive with seraclone anti-m clone bs57.The customer provided neither the supposedly defective product seraclone anti-m for investigational testing nor the patient sample that had caused a false positive test result.Therefore our quality control (qc) laboratory tested their retentions sample with different donor red blood cells.All positive and negative reactions were correct.Part of this testing were two different red blood cells which were he positive.Both yielded negative results with the retention sample of seraclone anti-m.We did not observe any false positive result.Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-m functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• Brand Name: BLOOD GROUPING REAGENT ANTI-M (MNS1); 2ML
• Type of Device: SERACLONE ANTI-N (MNS1)
• 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: 8003588
• MDR Text Key: 126078275
• Report Number: 9610824-2018-00074
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952021
• UDI-Public: (01)07611969952021(17)190901(10)2737111-00
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: 808410
• Device Lot Number: 2737111-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2018
• 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