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

Catalog Number	808184100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
Customer reported about false negative and too weak positive reactions with seraclone anti-jkb.The customer was running the positive control of the seraclone anti-jkb fusing multiple heterozygous positive cells and he found the reactions to be amazingly fragile and weak compared to previous lots of seraclone anti-jkb.The customer declared that he followed the product ifu according the directions.The customer did neither provide the complaint sample for investigational testing nor the red blood cells used as positive control.Therefore our quality control laboratory tested their retention sample of seraclone anti-jk(b) (ref.#: 808184100, lot #8937090-01, 2021-05-02) in parallel with lot #8026020-01.Both lots were tested manually for potency and specificity.For the potency as well as the positive specificity testing the tests were incubated for 15 minutes at room temperature and subsequently centrifuged for 60 seconds at 800 to 1000 x g.The minimum titer of 8 was always exceeded.For the testing of positive specificity jka+b+ heterozygous reagent red blood cells of biotest cell and panocell (immucor) were used.All positive reactions were correct and strongly positive.The reaction strengths were 3+ to 4+ positive.We did not observe any false negative respectively weakened reaction.The complaint was classified as undetermined because the complaint sample was not available for investigation and the retention sample reacted as expected.Without the possibility of testing the complaint sample and the red blood cells of customer the cause of the false negative reaction at customer¿s site remained 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-JK(B)
• Common Device Name: SERACLONE ANTI-JK(B)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 11062525
• Report Number: 9610824-2020-00092
• Device Sequence Number: 1193864
• Product Code: QHR
• UDI-Device Identifier: 07611969951796
• UDI-Public: (01)07611969951796(17)210502(10)8937090-01
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: 125217
• 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
• Report Date (Section B): 12/23/2020

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: 05/02/2021
• Device Catalogue Number: 808184100
• Device Lot Number: 8937090-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1