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	01/28/2022
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 a false negative reaction of one patient sample with both anti-d clones (clone (b)(6)) of erytype s abd+rev.A1, b when tested on tango infinity.The customer did neither return the product sample of 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 of a rhd positive sample.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Result images were provided that show negative results for rh(d), and also a grainy coloring in the well.A filed service engineer was at the customer's site to collect log files of the affected tango infinity instrument.The received databases and log files were analyzed for any issue relevant anomalies.The log files did not show any issue relevant abnormalities.Based on current information and data there is no indication for an instrument malfunction based on the investigation outcome, the complaint was classified as confirmed - epp (expected product performance).During the complaint investigation, the customer communicated that the sample was tested as weak d positive.The result was negative for rh(d) in both wells and on both days of testing.As the above limitation describes, weak d may show weak to negative reactions on the used erytype s configuration, the reported problem is related to sample specificities.The instructions for use blood grouping reagent erytype s abd+rev.A1,b contain a corresponding note in the section imitations: "category vii and very weak expressions of the d antigen (d weak with very few receptors) will give weakened or negative reactions with the anti-d reagents on this strip.".

• 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
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 13583063
• Report Number: 9610824-2022-00009
• Device Sequence Number: 5681239
• Product Code: QHR
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)220724(10)9104050
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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: 07/24/2022
• Device Catalogue Number: 806127100
• Device Lot Number: 9104050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TANGO INFINITY, SN (B)(4)
• Patient Sex: Unknown