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

Catalog Number	801325100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that two donors and one patient were typed as blood group b, but showed weakly positive reactions with seraclone anti-a.The customer returned the supposedly defective product and also the samples that had caused false positive reactions.Testin gin our quality control laboratory is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that two donor samples and one patient sample were typed as blood group b, but showed weak positive reactions with seraclone anti-a.The customer returned the supposedly defective product for investigational testing and also the samples that had caused false positive reactions.The two donor samples were provided as segments (pigtails) ((b)(6)) and the patient sample (b)(6)) consisted of red cells in a tube.Our quality control laboratory tested the donor and patient samples with the supposedly defective product in the method immediate spin according the instruction for use and yielded the following results: (b)(6).Because all samples did not contain any serum or plasma reverse typing and testing for irregular red cell antibodies was not possible.Due to the fact that segments (pigtails) are not suited for the molecular typing only one sample, (b)(6), was sent to an external laboratory for molecular abo typing.The result is: abo* b101 / b101.The correct function of the allegedly defective sample was confirmed by testing the negative and positive specificity as well as potency.The instruction for use of seraclone anti-a contains in the chapter "specific performance characteristics" a reference: seraclone® anti-a has the ability to detect minute quantities of a-antigens on red cells (e.G.Ax).However, this capability allows clinical insignificants numbers of a antigens to be detected as in rare cases of b individuals with elevated a antigen level (e.G.B(a) phenomena).Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-a functions correctly.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-A
• Common Device Name: SERACLONE ANTI-A
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6111919
• Report Number: 9610824-2016-00072
• Device Sequence Number: 280300
• Product Code: KSZ
• UDI-Device Identifier: 07611969950065
• UDI-Public: 07611969950065
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2017

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: 10/17/2017
• Device Catalogue Number: 801325100
• Device Lot Number: 8543110-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2016
• Supplement Report FDA Received Date: 01/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SERACLONE ANTI-A, LOT 8616070- 02,EXP. 04/10/2018; SERACLONE ANTI-A, LOT 851050-03, EXP. 04/10/2017