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

Catalog Number	806127100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined intial and final report on this incident.
Event or Problem Description
The customer reported failed patient blood groups when using erypece s abd+rev a1,b on tango optimo, because there was a "gob" in the reverse a1 cells which the tango interpreted as positive.He confirmed that the tango optimo is functioning properly.The customer mentioned that he received the affected product in boxes that were damaged and the plates he received were wet.These conditions should not have a negative impact to the quality of the erytype plates, because they are sealed in a special aluminum foil which is impermeable to water vapor.A negative impact cannot be excluded in case the sealing of the plates was damaged.In order to exclude a damaging of the sealing the customer was encouraged to return the plates for investigation.The customer did not provide the affected plates for investigational testing.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot erytype s abd+rev.A1, b with different donor samples on tango optimo.All positive and negative reactions were correct.We did not see any clumps in the reverse typing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• 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: 11364515
• Report Number: 9610824-2021-00003
• Device Sequence Number: 1101948
• Product Code: QHR
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)220501(10)8045010
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 02/23/2021

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: 05/01/2022
• Device Catalogue Number: 806127100
• Device Lot Number: 8045010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/23/2021
• 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 OPTIMO, SN (B)(4)