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 Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initail and final report on this incident.
Event or Problem Description
The customer reported that a patient sample of a pregnant woman showed a false negative reaction with seraclone anti-d (rh1) blend.The customer stated that the sample showed a 4+ positive reaction with anti-d of abo/rh gel card on ortho vision automated method.The tube testing with seraclone anti-d (rh1) blend was not taken to the indirect antiglobulin test (iat).The customer stated that he verified that all instructions of the instruction for use (ifu) were followed.The tube test was not repeated.The customer sent the patient sample for molecular rhd genotyping.The outcome of the investigation was rh(d) normal, not a variant or weak d.The customer did neither provide a sample of the allegedly defective product for investigational testing nor the patient sample that caused the false negative test result.Therefore, our quality control laboratory manually tested their retention sample of the supposedly defective lot for potency and specificity.The testing was done in parallel with a reference lot.The acceptance criterion for the minimum titer 32 was met.According to the ifu different red blood cell samples were manually tested in the immediate spin and the iat (30 min 37°c) test.All samples with a normal rh(d) showed strong positive results in the immediate spin test, while the weak d and the variant d samples reacted strongly positive in the iat.Within our tests all acceptance criteria were met.We did not observe any false negative reaction.The complaint was classified as undetermined: the complaint sample was not available for investigation and the retention sample reacted as expected.We did not receive any further complaints about this lot and issue.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 (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: 12390621
• Report Number: 9610824-2021-00060
• Device Sequence Number: 14354923
• Product Code: QHR
• UDI-Device Identifier: 07611969950201
• UDI-Public: (01)07611969950201(17)210826(10)8936080-03
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 08/31/2021

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: 8936080-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1