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	08/17/2019
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 of one patient sample when tested with seraclone anti-d blend in the tube method.The customer stated that the pre-natal patient was typed as blood group o rhd negative by two technicians on (b)(6) 2019.This result was confirmed by a quick stick test.On (b)(6) 2019 the same patient returned to have her abo/rh typing performed using the tube method.This time the result was rhd positive.For this testing the customer used seraclone anti-d blend lot 8905130-04.Due to the discrepant test results the customer thought the patient might have a variant and would like further tests performed.The customer did not return the supposedly defective product seraclone anti-d blend for investigational testing, but one patient sample.The testing in our quality control laboratory is still ongoing.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 result with seraclone anti-d (rh1) blend (ref#802033100, lot #8832110-02).The customer stated that she ran an abo/rh typing by tube test on a prenatal patient (acc #(b)(4)) on (b)(6) 2019.The patient was typed as blood group o rh(d) negative by two different technicians.The customer also ran a quick stick test and the results were blood group o rh(d) negative.On (b)(6) 2019 the same patient returned to have her abo/rh typing performed by tube method.The rh(d) reacted 3+ positive at immediate spin.In a repeat testing of the same sample the reaction strength was 1+ positive at immediate spin.The reagent used for the rh(d) typing was seraclone anti-d (rh1) blend (ref #802033100, lot #8905130-04).Due to the discrepant results the customer thought the patient might have a variant and wanted further testing performed.The customer determined the rh formular of the patient.It was ccee.The customer returned two patient samples (#(b)(6) , coll.(b)(6) 2019) for investigational testing, but not the complaint samples.Therefore our quality control laboratory tested both samples with their retention samples of seraclone anti-d blend lot #8832110-02 and lot #8905130-04.Both samples yielded 4w + positive reactions at immediate spin.Additionally both retention samples of seraclone anti-d blend were tested for potency and specificity.All acceptance criteria were met.The minimum titer was exceeded by both lots.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-d blend functions correctly.Due to the strong positive results of both samples at immediate spin a molecular typing of the rh(d) was not initiated.This was communicated to the customer.Based on this information the customer started thinking whether there was a tech error.A review of the batch record documentation showed no irregularities which might have negative influences on 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: 9567560
• Report Number: 9610824-2019-00082
• Device Sequence Number: 14175223
• Product Code: QHR
• UDI-Device Identifier: 07611969950201
• UDI-Public: (01)07611969950201(17)200729(10)8832110-02
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 07/29/2020
• Device Catalogue Number: 802033100
• Device Lot Number: 8832110-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 08/06/2020
• 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-D BLEND #8905130-04; SERACLONE ANTI-D BLEND #8905130-04