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

Catalog Number	802033100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant results after performing immediate spin using the seraclone anti-d (rh1) blend.The customer stated that the patient results were negative but when the reactions remained in the tube, the reaction changed to positive.The date of event was initially not provided by the customer but has been requested.The customer announced to ship a product sample of seraclone anti-d (rh1) blend for investigational testing.Our quality control laboaratory is still waiting for this sample to arrive in order to test it in parallel with their retention sample of the supposedly defective lot.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 iniitial report on this incident.
Event or Problem Description
The customer reported discrepant results after performing immediate spin, using the seraclone anti-d (rh1) blend.The customer stated that the patient results were negative but when the reactions remained in the tube, the reaction changed to positive.The customer returned two vials of the product sample seraclone anti-d (rh1) blend for investigational testing.Our quality control laboratory tested both samples for potency in parallel with their retention sample and a reference lot.All four reagent samples showed comparable results and met the minimum titer.In addition, both vials of the complaint sample were tested with different samples for the specificity of the methods described in the instructions for use (ifu), including the immediate spin method.All positive and negative reactions were correct.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Based on the investigation the complaint was classified as unjustified.Complaint sample and retention sample reacted as expected.All acceptance criteria regarding specificity and potency were met.Nevertheless we referred the customer to the following section of the instruction for use (ifu): "if the immediate reaction with anti-d (rh1) blend is negative, a test for weak d or partial d may be performed.Very weak antigen expression may not be detected.There is no monoclonal anti-d reagent, which will detect all parts of the d antigen." furthermore, we pointed out that the cell buttons must dislodged gently after centrifugation.Otherwise, the agglutinates of weak positive reactions might be destroyed.
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
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMNH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 19018390
• Report Number: 9610824-2024-00007
• Device Sequence Number: 20831548
• Product Code: QHR
• UDI-Device Identifier: 07611969950201
• UDI-Public: (01)07611969950201(17)250501(10)9319030-02
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: 05/01/2025
• Device Catalogue Number: 802033100
• Device Lot Number: 9319030-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown