MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-JK(A); SERACLONE ANTI-JK(A)

Catalog Number	808179100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 seraclone anti-jk(a) did not react as expected.The customer observed this issue with one patient sample.The reagent had been working fine until they had one patient react negative with anti-jka (heterozygous control reacted 1+ weak).Repeat testing using another vial of same lot of anti-jka got the patient reacting weak and the control 2+ (different control cell used).The customer used two drops of antisera, incubated for 30 minutes at room temperature (20-24c), spun for 20 seconds at 3500 rpm.The customer did not provide a date of event.The customer returned the complaint sample and also the patient sample that caused a false negative test result for investigational testing.Our quality control laboratory tested the complaint sample for potency and specificity in parallel with their retention sample and a reference lot.The minimum titer of 8 was exceeded.All three reagents (complaint sample, retention sample and reference lot) showed comparable results.Furthermore, the patient sample was tested with the complaint sample, the retention sample, and the reference lot.The testing was done with an incubation for 15 minutes and for 30 minutes at room temperature.In all cases the patient sample showed strong positive results.The reaction strength was 3+ respectively 4w positive.Quality control laboratory centrifuged 60 seconds at 823 x g.The complaint was classified as unjustified.The complaint sample and the retention sample reacted as expected.The patient sample of customer reacted strongly positive with the complaint sample.We advised the customer to follow the instruction for use (ifu) and centrifuge 60 seconds at 800 to 1000 x g.The shortened centrifugation time might be the cause for the false negative reaction at the customer´s site.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.An internal quality notification no.(b)(4) was raised because of the delay in filing this medical device report.

• Brand Name: BLOOD GROUPING REAGENT ANTI-JK(A)
• Common Device Name: SERACLONE ANTI-JK(A)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 13016070
• Report Number: 9610824-2021-00081
• Device Sequence Number: 5188266
• Product Code: QHR
• UDI-Device Identifier: 07611969951758
• UDI-Public: (01)07611969951758(17)220423(10)8036010-01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 125231
• 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): 12/16/2021

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: 04/23/2022
• Device Catalogue Number: 808179100
• Device Lot Number: 8036010-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: BIOTESTCELL-I11, LOT 9124011-00
• Patient Sex: Unknown