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	05/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a donor sample showed a false negative result with anti-d of erytype s abd+rev.A1, b on tango infinity.The customer stated that the donor sample should be used as a o rhd negative control.But then the donor sample showed a weak positive reaction with the anti-d of erytype rh confirm on tango infinity.Based on this result the customer tested the donor sample with seraclone anti-d blend in the tube technique.The sample showed a negative result in the immediate spin test, but a positive result in the indirect antiglobulin test (iat).The customer did not return the complaint sample of the supposedly defective lot erytype s abd+rev.A1, b, but the donor sample (#(b)(6)) that had caused a false negative test result.The donor sample was separated in plasma and red blood cells.Additionally, the customer returned seraclone anti- d blend.Our quality control laboratory tested the donor sample with their retention sample of erytype s abd+rev.A1, b and could confirm customer´s finding.Additionally, the donor sample was tested with seraclone anti-d blend in the tube technique.Again, the customer´s finding could be confirmed: a negative result in the immediate spin test, but a positive result in the iat.Due to the serological test results a weak d respectively a d variant was suspected.Therefore, the donor sample was sent for molecular typing to an external laboratory.We are still waiting for the result.The customer provided result images that confirm the negative results using abd+rev.A1,b plate and positive to intermediate results using erytype s rhd confirm plate.A field service engineer collected the requested files and viewed the instrument log.The instrument is operating per specifications and remains in operation.The log files confirm the discrepant results between both assays (plate types).We are still waiting for the outcome of the molecular typing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Additional Manufacturer Narrative
This is our initial report on this incident.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that a donor sample showed a false negative result with anti-d of erytype s abd+rev.A1, b on tango infinity.The customer stated that the donor sample should be used as a o rhd negative control but it showed a weak positive reaction with the anti-d of erytype rh confirm on tango infinity.Based on this result the customer tested the donor sample with seraclone anti-d blend in the tube technique.The sample showed a negative resullt in the immediate spin test, but a positive result in the indirect antiglobulin test (iat).The customer did not return the complaint sample of the supposedly defective lot erytype s abd+rev.A1, b, but the donor sample (#2308048) that had caused a false negative test result.The donor sample was separated in plasma and red blood cells.Additionally, the customer returned seraclone anti- d blend.Our quality control laboratory tested the donor sample with their retention sample of erytype s abd+rev.A1, b and could confirm the customer´s finding.Additionally, the donor sample was tested with seraclone anti-d blend in the tube technique.Again, the customer´s finding could be confirmed: a negative result in the immediate spin test, but a positive result in the iat.Due to the serological test results a weak d respectively a d variant was suspected.Therefore, the donor sample was sent for molecular typing to an external laboratory.The result of the external examination was ccd.Ee weak d type 1 (isbt: rhd*01w.1).Furthermore, the retention sample of the supposedly defective lot erytype s abd+rev.A1, b was tested with different donor samples on tango infinity.All positive and negative reactions were correct.Based on the investigation the complaint was classified as confirmed - epp (expected product performance).The patient sample was typed as ccd.Ee weak d type 1 (isbt: rhd*01w.1).This result matched the serological results, both at the customer's site and in our quality control laboratory.The instructions for use blood grouping reagent erytype® s abd+rev.A1,b contained 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." a review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Regarding the affected tango infinity, the received databases and log files were analyzed for any issue relevant anomalies.A field service engineer checked the instrument and found the instrument to be operating per specifications and remaining in operation.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.As the above limitation describes, weak d type 1 may show weak to negative reactions on the used erytype s configuration.The reported problem is 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: 11921234
• Report Number: 9610824-2021-00041
• Device Sequence Number: 847526
• Product Code: QHR
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)210912(10)8012230
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/12/2021

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: 09/12/2021
• Device Catalogue Number: 806127100
• Device Lot Number: 8012230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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: ERYTYPE RH CONFIRM, LOT 8006150.; ERYTYPE RH CONFIRM, LOT 8006150.; TANGO INFINITY, SN (B)(6).; TANGO INFINITY, SN (B)(6).