MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPE S ABD+REV A1,B

Catalog Number	806127100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our intial report on this incident.
Event or Problem Description
The customer reported dots or residuals in the wells of erytype s abd+rev.A1, b, that gave an error with the reaction result when used on tango infinity.The customer did neither the samples nor the supposedly defective product for investigational testing.Our quality control laboratory is also still waiting for further information regarding the customer's complaint and also for imagines that can demonstrate the issue.While waiting for the missing information, imagines and the complaint samples, our quality control laboratory started testing their retention sample of the allegedly defective product erytype s abd+rev.A1,b.This testing 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.
Event or Problem Description
The customer reported some dots or residuals in the wells of erytype s abd+rev.A1, b.The observed dots caused false positive results on tango infinity.Because the customer did not return the complaint sample of erytype s abd+reva1,b for investigatinal testing, our quality control laboratory tested their retention sample of the supposedly defective lot and erytypecell a1&b lot #9102011-00 and #9106011-00 with different donor samples on tango infinity.All positive and negative reactions were correct.We did not observe any dots or residuals.All negative reactions were clearly negative.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 was inspected by one of our field service engineers.The information provided by the field service engineer confirmed that the instrument was within manufacturer means and was returned to the customer for normal use.According to the field service engineer, the customer let the erytype plates not come to room temperature before loading on the instrument.The customer was informed that they should let the plates come to room temperature before opening the package and loading the plate onto the tango infinity.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: ERYTYPE S ABD+REV A1,B
• Common Device Name: ERYTYPE S ABD+REV A1,B
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 11403340
• Report Number: 9610824-2021-00006
• Device Sequence Number: 20023598
• Product Code: QHR
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)210606(10)8950190
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 125094
• 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): 03/12/2021

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: 06/06/2021
• Device Catalogue Number: 806127100
• Device Lot Number: 8950190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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: TANGO INFINIY, SN (B)(6); TANGO INFINIY, SN (B)(6)