MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND; SERACLONE® ANTI-D (RH1) BLEND; 10X10ML

Catalog Number	802033100
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	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our inital report on this incident.
Event or Problem Description
The customer reported too weak positive respectively false negative results of three patient samples with seraclone anti-d blend.The testing was performed manually.The customer returned the allegedly defective product sample for investigational testing and the three patient samples, labeled as (b)(6).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.
Event or Problem Description
The customer reported too weak positive respectively false negative results of three patient samples with seraclone anti-d blend.The customer returned the complaint sample and three patient samples for investigational testing.Our quality control laboratory tested the returned product sample for potency and specificity in the tube technique.The testing was done in parallel with our qc lab's retention sample and a reference lot.The minimum titer was always met and all three reagents showed comparable results.The patient samples were tested in the immediate spin method and showed negative respectively +/- reactions.Then the patient samples were tested in the indirect antiglobulin test and showed strong positive results.Due to the test results the patient samples were sent for further investigation to an external laboratory.The outcome of the external molecular typing of the rh formula and the sequencing was: sample # (b)(6): cc.Ee, rhd * weak d type 4.0 (rhd * 09.03.01).Sample # (b)(6): ccd.Ee weak d type 3 (rhd * 01w.3).Sample # (b)(6): cc.Ee, rhd *weak d type 4.0 (rhd * 09.03.01).Additionally, both the complaint sample and the retention sample were tested with different donor samples.All positive and negative reactions were correct.Based on the outcome of the internal and external investigation the complaint was classified as confirmed - epp (expected product performance).The complaint sample and the retention sample reacted as expected.The results of the external investigation of the patient samples were the explanation for the reaction pattern of the samples with seraclone anti-d blend.According to the instruction for use a test for weak d is recommended in case the immediate spin test is negative.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.

• Brand Name: BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND
• Common Device Name: SERACLONE® ANTI-D (RH1) BLEND; 10X10ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 11482479
• Report Number: 9610824-2021-00009
• Device Sequence Number: 17113039
• Product Code: QHR
• UDI-Device Identifier: 07611969950201
• UDI-Public: (01)07611969950201(17)210826(10)8936080-02
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: 125223
• 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,Followup
• Report Date (Section B): 04/23/2021

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: 08/26/2021
• Device Catalogue Number: 802033100
• Device Lot Number: 8936080-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1