MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL 3

Catalog Number	816085100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative respectively discrepant antibody screen results for anti-c when testing with biotestcell 3 on tango optimo.The reaction in one of the cells appeared visually positive (1+) but tango optimo gave a negative reaction.The sample was re-tested in the tube test and yielded a positive screen and it was identified as an anti-c.The customer returned the patient samples that had caused discrepant results for investigational testing.Testing in our quality control laboratory is still ongoing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected tango optimo was inspected by one of our field service engineers and found to be working within specifications.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that a patient sample yielded a negative reaction with biotestcell 3 when used on tango optimo.The customer stated that the reaction appeared visually to be positive.He also reported that the patient sample was tested in tube technique and an anti-c was detected.The customer returned neither the supposedly defective product for investigational testing nor the patient sample that had caused the false negative test result.At the time the cusotmer filed his complaint, the affected lot of biotestcell 3 had already expired.Therefore the retention sample could not be tested.Originally the customer had said to send in the patient sample and also a patient sample for investigational testing.But upon request we were informed that the patient sample belonged to a different complaint case.Due to the fact that the supposedly defective product was expired and no patient sample was available, an investigation could not be conducted.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected tango optimo was inspected by one of our field service engineers and found to be working within specifications.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 3
• Common Device Name: BIOTESTCELL 3
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7888757
• Report Number: 9610824-2018-00060
• Device Sequence Number: 169913
• Product Code: KSZ
• UDI-Device Identifier: 07611969952687
• UDI-Public: (01)07611969952687(17)180827(10)8827011-00
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2018
• Device Catalogue Number: 816085100
• Device Lot Number: 8827011-00
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TANGO OPTIMO, # 9142400384; TANGO OPTIMO, # 9142400384