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

Catalog Number	802033100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported discrepant d typing results compared to other reagents (ortho, immucor).Testing of a patient sample with seraclone anti-d (rh1) blend gave +/- result at immediate spin, 1+ after incubating 10 minutes at 37 degrees, and when tested at ahg it gabe 4+ results.The same sample gave a 3+ result when tested in immediate spin using ortho anti-d but yielded an 1+ reaction in the immediate spin using immucor anti-d.The customer announced to send the supposedly defective product that had caused discrepant respectively weakened results for investigational testing.We are still waiting for this 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 discrepant rh(d) typing result compared to the test result when reagents of competitors were used.This site reported a rh(d) negative result on a pre-natal patient sample with seraclone anti-d blend (ref #: 802033100, lot #: 8905130-04).The patient gave birth and the hospital where she delivered reported a rh(d) positive test result when using ortho reagents.The customer took another patient sample about 3 weeks ago and retested it: in the immediate spin method they yielded a +/- reaction, a 1+ positive reaction after incubating 10 minutes at 37°c and a 4+ positive reaction in the indirect anti-globulin test.The customer returned the complaint sample seraclone anti-d blend for investigational testing but not the patient sample that had caused a false negative test result.Our quality control laboratory tested the complaint sample as well as their retention sample and also a reference lot (lot #: 8922070-04) for potency and specificity.All reactions were correct.The minimum titer of 32 was exceeded.And all three reagents (complaint sample and retention sample of the supposedly defective product as well as the retention sample of the reference lot) showed comparable results.Seraclone anti-d blend is formulated to optimize the reaction at anti-human globulin (ahg) and therefore might give weaker reactions at immediate spin method.According to the note in the section limitation of the instruction for use we recommend: "if the immediate reaction with anti-d (rh1) blend is negative, a test for weak d or partial d may be performed." testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-d blend 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-D BLEND
• Common Device Name: SERACLONE ANTI-D BLEND
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 8953426
• Report Number: 9610824-2019-00048
• Device Sequence Number: 189316
• Product Code: KSZ
• UDI-Device Identifier: 07611969950201
• UDI-Public: (01)07611969950201(17)210119(10)8905130-04
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 01/19/2021
• Device Catalogue Number: 802033100
• Device Lot Number: 8905130-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 09/02/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1