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

Catalog Number	816047100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported weak positive to false negative reactions with biotestcell-a2 when they were expected to be clearly positive.The customer stated that she observed this issue when performing manual qc with immucor core qc kit.The customer did not provide the complaint sample biotestcell-a2 for investigational testing.Therefore; our quality control laboratory tested their retention sample of the supposedly defective lot with different donor samples for potency and specificity.All acceptance criteria were met.All positive and negative reactions were correct.We did not observe any false negative respectively weakened reaction.A review of the batch record documentation showed no irregularities, which might have negatively affected the quality of the allegedly defective lot.The complaint investigation showed that the customer did not use the correct ifu and did not realize the statement under the test procedure to incubate for 15 to 30 minutes if necessary.The customer incubated for an additional 15 minutes and the reaction came up as 2+ positive.The customer informed us that she received the correct results after following the instruction for use and incubating the test for 15 minutes.Based on the investigation and the information of the customer the complaint was classified as unjustified.
Additional Manufacturer Narrative
This is our combined intital and final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL A2
• Common Device Name: BIOTESTCELL A2
• 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: 14998514
• Report Number: 9610824-2022-00035
• Device Sequence Number: 1881050
• Product Code: QHT
• UDI-Device Identifier: 07611969952625
• UDI-Public: (01)07611969952625(17)220704(10)9218011-00
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: 125207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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: 07/04/2022
• Device Catalogue Number: 816047100
• Device Lot Number: 9218011-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOTESTCELL A2, LOT 9222011-00; IMMUCOR QC A2, LOT 15122
• Patient Sex: Unknown