MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPECELL A1 & B; ERYTYPECELL A1 & B, 2X10 ML

Catalog Number	816056100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
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 positive reaction of one patient sample with erytypecell b when used on two instruments, the tango infinity and the tango optimo.Because neither the complaint sample nor the patient sample were available for investigation,our quality control laboratory tested their retention sample with different donor sample on both instruments.The testing was done in parallel with a reference lot of erytypecell a1&b (lot #9106011-00).All positive and negative reactions were correct.We did not observe any false positive result.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Images of the incident have so far not been provided.Since the same results were observed on both, the tango infinity and the tango optimo, an instrument issue is most likely not the cause.Further investigations are not possible without further information.We are waiting for additional information, images and log files.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
Customer reported false positive reactions of erytypecell a1 & b in the b cell while reverse typing.The customer was in the process of validating his tango infinity, to which he switched from tango optimo.Both instruments showed the same reactions.They did not run an antibody screen on the sample.The customer did not provide images for review.Since the customer was in the process of validating the instrument, no previous preventive maintenance has been conducted.Since the same results were observed on both, the tango infinty and on tango optimo, an instrument issue is most likely not the case.Log files for investigation were not provided by the customer.The customer did neither provide the complaint sample for investigational testing nor the patient sample.The patient sample was no longer available.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot erytypecell a1&b (ref #816056100, lot #9102011-00, exp.2021-03-15) with erytype s abd+rev.A1, b (ref #806127100, lot #8005120) on tango optimo and tango infinity.The testing was done in parallel with a reference lot of erytypecell a1&b (lot #9106011-00).All positive and negative reactions were correct.We did not observe any false positive result.Without the possibility to test the affected patient sample, the cause of the positive reaction remained unknown.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.From the instrument's perspective, based on current information there is no indication for an instrument malfunction.There is no discrepancy between the instruments.The reported problem is likely related to sample specificities.

• Brand Name: ERYTYPECELL A1 & B
• Common Device Name: ERYTYPECELL A1 & B, 2X10 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 11516852
• Report Number: 9610824-2021-00013
• Device Sequence Number: 3430437
• Product Code: QHT
• UDI-Device Identifier: 07611969952656
• UDI-Public: (01)07611969952656(17)210315(10)9102011-00
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: 125208
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 03/15/2021
• Device Catalogue Number: 816056100
• Device Lot Number: 9102011-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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: ERYTYPE S ABD+REV.A1, B, LOT 8005120; ERYTYPE S ABD+REV.A1, B, LOT 8005120; TANGO INFINITY, SN 4230000270; TANGO INFINITY, SN 4230000270; TANGO OPTIMO; TANGO OPTIMO