MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-PANEL 11; IH-PANEL 11; 11X4 ML

Catalog Number	814070100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that a patient sample with a known anti-c yielded a 3+ reaction when tested with donor #4 of ih-panel 11.The panel was run on ih-500.The anti-v or anti-vs result was yielded using immucor cells in peg.Testing in our quality control laboratory is still ongoing.
Event or Problem Description
The customer reported that a patient sample with a known anti-c yielded a 2+ reaction when tested with donor #4 of ih-panel 11 (#550078), which was negative for the c antigen (ror).The anti-c had been re-identified with reagent red blood cells positive for the c antigen.The panel was run on the ih-500 analyzer.The customer just wanted to report that the donor #4 is positive for the v/vs antigen, which they confirmed by internal testing.The customer did not return the supposedly defective product for investigational testing but provided the affected patient sample as well as images of their test results.Therefore our quality control laboratory tested their retention sample of ih-panel 11, lot 8007011 on ih-500 with different donor blood samples as well as known antibodies (including anti-d and anti-c) on the ih-card ahg anti-igg which was used by the customer.Each sample reacted as expected.The deployed antibodies reacted according to the antigen pattern of the worksheet ih-panel 11.Donor #550078 of ih-panel panel 11 as well as the provided patient sample were sent to a reference laboratory which confirmed that the affected donor #550078 of ih-panel 11 was positive for the v/vs antigen.Furthermore, an anti-c (enzyme-depending), an very weak reacting anti-d as well as anti-v/vs were detectable in the patient sample provided by the customer.Based on this test results, an appropriate comment was stored in the database to donor #550078.In case of a further deployment of this donor the worksheet will contain an extra note: v+/vs+.Testing by our quality control laboratory confirmed that the allegedly defective lot of ih-panel 11 functioned correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Even though the complaint was patient related, a special comment was assigned to this donor for the reagent red blood cells.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLS IH-PANEL 11
• Common Device Name: IH-PANEL 11; 11X4 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 9920941
• Report Number: 9610824-2020-00012
• Device Sequence Number: 3931641
• Product Code: QHT
• UDI-Device Identifier: 07611969952298
• UDI-Public: (01)07611969952298(17)200406(10)8007011
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: 04/06/2020
• Device Catalogue Number: 814070100
• Device Lot Number: 8007011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IH CARD AHG ATNI-IGG, LOT 8946100; IH CARD AHG ATNI-IGG, LOT 8946100; IH-500, # 5500022; IH-500, # 5500022; IH-CELL I-II-III, LOT 8007011; IH-CELL I-II-III, LOT 8007011