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 Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative result with seraclone anti-k and kell positive reagent red blood cells.The customer announced to send in a sample of the allegedly defective product for investigational testing and also the specimen that had caused the false negative test result.Our quality control laboratory is still waiting for the material of the ustomer to start testing of the complaint sample in parallel with the retention sample.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.
Event or Problem Description
The customer reported a false negative result with seraclone anti-k and kell positive reagent red blood cells.Her performed the qc testing using cell i of ih-cells i-ii-iii, lot 9302011 (ref 814030100) as the positive control.Following the ifu there was no reaction with k positive and k negative cells in the panel.The customer returned a sample of the allegedly defective product seraclone anti-k for investigational testing and also the ih-cell i-ii-iii which caused the false negative reaction.At the time we received the material on our premises, the cells ih-cell i-ii-iii were already expired.Our quality control laboratory tested the product sample returned by the customer in parallel with their retention sample and the reference lot for potency and specificity.Different donor samples were used for these tests.The testing was performed according to the method described in the instruction for use (ifu): tube test with an incubation for 5 minutes at room temperature and a centrifugation for 20 seconds at 800-1000 x g; then the red blood cell buttons were gently dislodged, and the reactions rated.All acceptance criteria were met.The minimum titer of 16 was exceeded.The positive specificity was additionally checked with panel cells of biotestcell-i11 plus according to the ifu.The reactions with the k positive reagent red blood cells were clear and strongly positive.Based on these tests, our quality control laboratory could not confirm the customer´s finding.The customer used ih-cells for his tests.Our quality control laboratory did not use ih-cells for the following reasons: they do not have the correct concentration for the tube test, the method for which seraclone anti-k is approved.The intended use of the ih-cells is the ih gel system and not the tube method.Based on our investigation the complaint was classified as unjustified.The complaint sample as well as the retention sample reacted as expected and met all specifications regarding potency and specificity.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• 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: 16589733
• Report Number: 9610824-2023-00012
• Device Sequence Number: 3022054
• Product Code: QHR
• UDI-Device Identifier: 07611969951574
• UDI-Public: (01)07611969951574(17)230708(10)9202040-01
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 05/02/2023

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: 07/08/2023
• Device Catalogue Number: 808090100
• Device Lot Number: 9202040-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/02/2023
• 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: IH-CELLS I-II-III, LOT 9302011; IH-CELLS I-II-III, LOT 9302011
• Patient Sex: Unknown