MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-PANEL 11; IH-PANEL 11; 11X4 ML (REAGENT RED BLOOD CELLS FORMULATED FOR USE IN AUTOMATED

Catalog Number	814070100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported a false negative reaction with ih-panel 11 on the ih-1000 instrument.The customer stated that the specificity of the missed antibody was anti-e.According to the antigen table the reagent red blood cells #2 and #6 were e antigen positive and therefore supposed to react positively.The customer stated that the patient sample showed weak positive reactions with ih-panel plus 6.Therefore, the customer complained only about the ih-panel 11.The exact date of event is not known, so we assumed the date of awareness also to be the date of event.The customer did neither provide the complaint sample of the allegedly defective lot for investigational testing nor the patient sample that caused the false negative reaction.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot on the ih-1000.The testing was performed with known antibodies (anti-e, anti-d and anti-fy(a)) and donor samples.All positive and negative reactions were correct.The anti-e could be identified without any issue.Additionally, the e antigenicity of the claimed lot was compared to other homozygous and heterozygous e antigen positive reagent red blood cells (rrbcs).This potency testing was done manually.All e antigen homozygous rrbc yielded the same titer, the titer of the e antigen heterozygous rrbcs were one to two titer steps lower due to the different zygosity.The testing confirmed that the e antigenicity of the claimed ih-panel 11 lot was not weakened.Due the lack of the data files of the instrument an investigation of the involved ih-1000 was not possible.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• Brand Name: REAGENT RED BLOOD CELLS IH-PANEL 11
• Common Device Name: IH-PANEL 11; 11X4 ML (REAGENT RED BLOOD CELLS FORMULATED FOR USE IN AUTOMATED
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 15572396
• Report Number: 9610824-2022-00063
• Device Sequence Number: 12307174
• Product Code: QHT
• UDI-Device Identifier: 07611969952298
• UDI-Public: (01)07611969952298(17)220926(10)9230011
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: 125208
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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: 09/26/2022
• Device Catalogue Number: 814070100
• Device Lot Number: 9230011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IH PANEL 6, LOT 9231100; IH-1000, SN (B)(4)
• Patient Sex: Unknown