MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-CELL A1 & B; IH-CELL A1 & B; 2X10 ML

Catalog Number	814010100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant results of two patient samples with ih-cell a1&b on the ih-1000 instrument.Both patient samples were known to be blood group o rhd positive.The customer did neither provide the complaint sample ih-cell a1&b for investigational testing nor the customer sample that had caused the discrepant result.Therefore our quality control laboratory tested their retention sample of the allegedly defective lot with different donor samples on the ih-1000.All positive and negative reactions were correct.We did not observe any discrepancies.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Data files of the affected ih-1000 instrument are under investigation, this investigation is also still ongoing.
Additional Manufacturer Narrative
This is our initial report on this incident.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported discrepant results of two patient samples with ih-cell a1&b on the ih-1000 instrument.Both patient samples were known to be blood group o rhd positive.The customer did neither provide the complaint sample ih-cell a1&b for investigational testing nor the customer sample that had caused the discrepant result.Therefore our quality control laboratory tested their retention sample of the allegedly defective lot with different donor samples on the ih-1000.All positive and negative reactions were correct.We did not observe any discrepancies.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Data files of the affected ih-1000 instrument were analyzed.The distribution sequence of the reverse grouping is correct and we did not notice any issues.The volume dispensed (cells + serum) on the wells a1 and b was correct.The positive result with ih-cell a1 and b were as expected.Both samples were blood group o.According to the trace files analysis, a malfunction of the affected instrument can be excluded.Based on the investigation the complaint was classified as unjustified.

• Brand Name: REAGENT RED BLOOD CELLS IH-CELL A1 & B
• Common Device Name: IH-CELL A1 & B; 2X10 ML
• 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: 15575952
• Report Number: 9610824-2022-00062
• Device Sequence Number: 14179667
• Product Code: QHT
• UDI-Device Identifier: 07611969952243
• UDI-Public: (01)07611969952243(17)220926(10)9230021
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,Followup
• Report Date (Section B): 10/24/2022

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: 814010100
• Device Lot Number: 9230021
• 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
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 10/24/2022
• 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-1000, SN (B)(4); IH-1000, SN (B)(4); IH-CARD ABO/D(DVI-)+REVA1,B, LOT 9147030; IH-CARD ABO/D(DVI-)+REVA1,B, LOT 9147030
• Patient Sex: Unknown