MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLSBIOTESTCELL-I11 PLUS

Catalog Number	816022100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
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 result of a patient sample when tested with biotestcell-i11 plus on tango infinity.The customer stated that the specificity of the known antibody is anti-d due to the rh(d) prophylaxis.The customer returned neither the supposedly defective product nor the patient sample that had caused false negative test result.Testing of our retained product sample 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 both allegedly defective lot.The affected tango infinity has been inspected by our field service engineers and found to be working within specifications.
Event or Problem Description
The customer reported false negative results of a patient sample when tested with biotestcell-i11 plus on tango infinity.The customer stated that the specificity of the known antibody is an acquired anti-d due to the rh(d) prophylaxis.The patient sample was supposed to yield positive reactions with cell #1, #2, #3 and #4 of biotestcell-i11 plus.The customer returned neither the allegedly defective product sample for investigational testing nor the patient sample that had caused a false negative test result.Therefore our quality control laboratory tested their retention sample of biotestcell-i11 plus with controls and donor samples.All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed the allegedly defective lot of biotestcell-i11 plus functions correctly.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 infinity has been inspected by our field service engineers and found to be working within specifications.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLSBIOTESTCELL-I11 PLUS
• Common Device Name: BIOTESTCELL-I11 PLUS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7808413
• Report Number: 9610824-2018-00051
• Device Sequence Number: 2447198
• Product Code: KSZ
• UDI-Device Identifier: 07611969952441
• UDI-Public: (01)07611969952441(17)180827(10)8827011-00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 816022100
• Device Lot Number: 8827011-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/23/2018
• 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: BIOTESTCELL 3, LOT 8827021-00; BIOTESTCELL 3, LOT 8827021-00; TANGO INFINITY, # 4230000157; TANGO INFINITY, # 4230000157