MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-K (KEL1); SERACLONE ANTI-K

Catalog Number	808090100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false positive results with seraclone anti-k.The customer returned the complaint sample of the supposedly defective lot for investigational testing.Testing in our quality control laboratory is still ongoing.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.
Event or Problem Description
The customer reported false positive results with seraclone anti-k.The customer returned the complaint sample of the supposedly defective lot for investigational testing.Our quality control (qc) laboratory tested the complaint sample with different donor samples and confirmed the customer´s finding.The customer's complaint sample was tested in parallel with the retention sample of our qc and a reference lot.Both, the retention sample of the affected lot as well as the reference lot, showed correct results.The complaint sample was also visually examinated: the complaint sample showed neither turbidity nor impurities and looked like the qc retention sample.Additionally, the complaint sample was tested for potency in parallel with our qc's retained sample and the reference lot.The complaint sample showed two titer steps less than the qc retainted sample and the reference sample.Theoretically, a contamination with anti-k, anti-kpb, anti-jsb or anti-lu(b) could have caused the positive reactions in the complaint sample.Therefore, our qc lab tested the complaint sample with a frozen sample of a kell zero donor that was k, kp(b) and js(b) negative.The complaint sample showed completely negative reactions with this donor sample.The correct function of the donor sample was confirmed with an anti-lu(b).Here, the kell zero sample 3+ reacted positively.The qc sample and the reference sample also showed correctly negative results with the sample of the kell zero donor.Based on this investigation a contamination with anti-lu(b) could be ruled out.There were not the appropriate red blood cells available to rule out a contamination with anti-k, anti-kp(b) and anti-js(b).Based on the investigation the complaint was classified as confirmed - upp: unexpected product performance.The type of contamination remained unknown.We did not receive any further complaint about this lot and topic.A general lot problem can be excluded, especially since our qc lab tested both the first vial filled and a vial filled after the customer's sample.These two vials reacted specifically.Only the customer sample yielded a false positive reaction.No other reagent was filled on the day in question that could have caused a contamination.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 final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT ANTI-K (KEL1)
• Common Device Name: SERACLONE ANTI-K
• 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: 13016376
• Report Number: 9610824-2021-00082
• Device Sequence Number: 5188274
• Product Code: QHR
• UDI-Device Identifier: 07611969951574
• UDI-Public: (01)07611969951574(17)220907(10)9111010-01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 125230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 09/07/2022
• Device Catalogue Number: 808090100
• Device Lot Number: 9111010-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/12/2022
• 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
• Patient Sex: Unknown