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 Problem False Positive Result (1227)

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

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported a false positive reaction of a patient sample when testing with ih-cell b on ih-1000.The patient has the known blood group b.The customer repeated the testing in the tube technique and received the correctly negative result with the b positive cell.The customer also reported a false negative result of a patient sample with ih-cell b.Customer repeated the testing and received the correct result.The customer did not return the supposedly defective product ih-cell a1&b for investigational testing but said to send back the patient sample that had caused false positive test result.In the meantime our quality control laboratory tested their retention sample of ih-cell a1&b with different samples on ih-1000.All positive and negative reactions were correct.We did not observe any false positive result.Our quality control laboratory will test the patient sample as soon as it is returned for further investigation by the customer.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 negatively affected the quality of both allegedly defective lots.

Event Description

The customer reported a false positive reaction of a patient sample when testing with ih-cell b on ih-1000.The patient has the known blood group b.The customer repeated the testing in the tube technique and received the correctly negative result with the b positive cell.The customer also reported a false negative result of a patient sample with ih-cell b.Customer repeated the testing and received the correct result.The customer did neither return the supposedly defective product for investigational testing and and contrary to his announcement he also did not send in the patient sample that had caused a false positive test result.Therefore our quality control laboratory tested the retention sample of ih-cell a1&b with different samples on ih-1000.All positive and negative reactions were correct.We did not observe any false positive result.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 negatively affected the quality of the allegedly defective lot.

Manufacturer Narrative

This is our final report on this incident.

• 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
• MDR Report Key: 7964637
• MDR Text Key: 125460536
• Report Number: 9610824-2018-00068
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952243
• UDI-Public: (01)07611969952243(17)180924(10)8831011
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2018
• Device Catalogue Number: 814010100
• Device Lot Number: 8831011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IH-1000, # 5100050; IH-1000, # 5100050