MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-C (RH4); SERACLONE ANTI-C

Catalog Number	802346100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive reaction with seraclone anti-c (rh4).The customer returned a product sample for investigational testing.The returned sample was visually inspected in comparison to the retention samples stored in our quality control laboratory with the label numbers #00002, #00324 and the retention sample with the label number #00238.A slight cloudiness and a more intense yellowish color were noticeable in the sample returned by the customer.Additionally, the complaint sample was tested for specificity with various red blood cells and the customer´s finding was confirmed.The complaint sample showed unexpected positive results with c (rh4) antigen negative red blood cells.For further tests, the red blood cells used were selected in order to be able to identify the specificity of the contamination of the customer vial.Contamination with seraclone anti-d and seraclone anti-e was clearly ruled out.Based on the test results that all c positive cells showed a positive result, a contamination with seraclone anti-c was very likely.The retention sample was tested for specificity and potency and met all acceptance criteria.The unexpected false positive reactions were only observed with the vial of customer.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot since the false positive result for the vial in question did not occur immediately after opening, the retention sample reacted correctly and no further complaints have been received, a general lot problem can be ruled out.Based on the test results with different red blood cells and the coloration of the reagents that the customer received, a contamination with seraclone anti-c can be strongly assumed.It is highly likely that the customer has compromised his vial himself, e.G.By mixing up the sealing caps with the integrated dropper pipettes.The customer had also received seraclone anti-c, among other blood grouping reagents.
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT ANTI-C (RH4)
• Common Device Name: SERACLONE ANTI-C
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 19019628
• Report Number: 9610824-2024-00008
• Device Sequence Number: 14458254
• Product Code: QHR
• UDI-Device Identifier: 07611969950461
• UDI-Public: (01)07611969950461(17)240301(10)9249010-01
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: 125227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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: 03/01/2024
• Device Catalogue Number: 802346100
• Device Lot Number: 9249010-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown