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

Catalog Number	806127100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported that a patient showed a false negative rh(d) result when the sample was tested using erytype s abd+rev a1,b on tango infinity.The patient had been tested rh(d) positive on tango optimo the previous year.The rh(d) positive result was now confirmed by another laboratory.The customer returned neither the complaint sample erytype s abd+rev.A1, b for investigational testing nor the patient sample that had caused the false negative test result.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot with different donor samples on tango infinity.All positive and negative reactions were correct.We did not observe any false negative reaction.Regarding the affected tango infinity: the customer provided a black/white result image of poor quality that shows a negative reaction for both anti-d wells.The last preventative maintenance date was on (b)(6) 2021 and the service engineer confirmed a proper function of the instrument.The qc was run and passed all requirements.Due to the missing samples, the negative results at customer´s site remained unknown.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Based on current information and data there is no indication for an instrument malfunction.The qc passed at the days of issue.The result was negative for rh(d) in both wells and on both days of testing.The one available result image shows normal negative reactions.The reported problem is likely related to sample specificities.

• 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: 11753731
• Report Number: 9610824-2021-00026
• Device Sequence Number: 17003890
• Product Code: QHR
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)210606(10)8950190
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 04/30/2021

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: 04/01/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1