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

Catalog Number	808090100
Medical Device Problem Codes	False Negative Result (1225); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported weak respectively false negative reactions when using seraclone anti-k lot 8005050-01.The customer tested the reagent against multiple k+ reagent red cells and was getting negative or weak positve results for her positve control.Investigation of this complaint is still ongoing, so is testing in our quality control laboratory.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported weakened positive and false negative reactions with seraclone anti-k (ref #808090100, lot #8005050-01).The customer submitted her two vials seraclone anti-k and the panel cell that had caused false negative test results.Our quality control laboratory tested seraclone anti-k for potency and specificity.Test method for potency and positive specificity: incubation for 5 minutes at room temperature, centrifugation for 20 seconds at 823 x g.Test method for negative specificity: incubation for 5 minutes and 60 minutes at room temperature and 60 minutes at 37 °c with subsequent centrifugation.Within the potency testing the complaint samples (both vials) were tested in parallel with our quality control lab's retention sample and a reference lot (lot #8013040-01).The minimum titer of 16 was exceeded by all vials.For the specificity testing we used the immucor panel cell provided by the customer, heterozygous cells of biotestcell (biotestcell p lot #2041011-00 and cell #2 of biotestcell-i11 lot #8041011-00) and cell #7 of panocell 10 (lot #35435).All reagent red blood cells yielded correctly positive results.Based on our test results we cannot confirm the customer´s finding.The vials submitted by the customer showed comparable results to the retention sample as well as the reference lot.We did neither observe any weakened nor false negative results.Additionally the test for negative specificity was performed using two different k negative red blood cells.All vials (both of customer, retention sample and reference lot) met the acceptance criterion and showed correctly negative results.The root cause of the false negative results at customer´s site remains unknown.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
• MDR Report Key: 10704820
• Report Number: 9610824-2020-00071
• Device Sequence Number: 19867305
• Product Code: QHR
• UDI-Device Identifier: 07611969951574
• UDI-Public: (01)07611969951574(17)210720(10)8005050-01
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 07/20/2021
• Device Catalogue Number: 808090100
• Device Lot Number: 8005050-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1