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	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative result of a patient with the ih-cell b of ih-cell a1&b on ih-1000.The customer did not provide the complaint sample for investigational testing.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot with different donor samples on ih-1000.All positive and negative reactions were correct.We did not observe any false negative reactions.The customer provided the patient sample for investigational testing.The investigation in our quality control laboratory is still ongoing.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 final report on this incident.
Event or Problem Description
The customer reported a false negative result of a patient sample with the ih-cell b of ih-cell a1&b when tested on ih-1000.The customer did not provide the product sample for investigational testing.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot of ih-cell a1&b with different donor samples with focus on blood group a and o on ih-1000.All positive and negative reactions were correct.We did not observe any false negative reaction in the reverse typing.The customer did provide the patient sample that had yielded a false negative reaction.At the time the patient sample arrived on our premised, the lot of ih-cell a1&b the customer had used when obtaining a false negative test result had already expired.Therefore our quality control laboratory tested the patient samplet with the current lot of ih-cell a1&b and could confirm the customer´s finding.The reaction with ih-cell b was false negative.The patient sample was also tested in the tube test and showed a correct positive result with biotestcell b.Furthermore, the current lot of ih-cell a1&b was tested with different donor samples on ih-1000.All positive and negative reactions were correct.The trace files of the affected instrument ih-1000 were checked.They showed that the volume dispensed on the b wells is in the range.The pictures showed the yellow color on the wells, demonstrating that the cells b and serum were correctly mixed on the incubation chamber of the ih card.Based on the investigation the complaint was classified as confirmed - epp: expected product performance.The negative reaction of the patient sample was confirmed, the complaint sample was not available for investigation and the retention sample reacted as expected.It is well known that the gel method is inferior to the tube method for reverse typing.This is since smaller amounts of plasma are pipetted in the gel, shear forces are also at work in the gel method and a greater surface of the red blood cells in the tube method.The sample was from a 77-year-old patient.The instruction for use contains an appropriate note in the section limitation: "decreased abo antibody reactivity may be seen with low titer isoagglutinin antibodies may be caused by disease states, the elderly or infants resulting in false negative reactions." 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-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: 12916033
• Report Number: 9610824-2021-00079
• Device Sequence Number: 17572490
• Product Code: QHT
• UDI-Device Identifier: 07611969952243
• UDI-Public: (01)07611969952243(17)211122(10)9138021
• 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,Followup
• Report Date (Section B): 01/27/2022

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: 11/22/2021
• Device Catalogue Number: 814010100
• Device Lot Number: 9138021
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/27/2022
• 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)(6) ; IH-1000, SN (B)(6) ; IH-CARD ABO/D(DVI-)+REV A1,B, LOT 9129010; IH-CARD ABO/D(DVI-)+REV A1,B, LOT 9129010
• Patient Sex: Unknown