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	09/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false negative reactions of two patient samples with ih-cell a1.Both patient samples had blood group b.Because the complaint sample was not available for investigation within its shelf life, our quality control laboratory tested their retention sample of the supposedly defective lot.Different donor samples were manually tested in parallel with a reference lot.All positive and negative reactions were correct.We did not observe any false negative reaction.Additionally, the donors of the supposedly defective lot were tested for potency in parallel with the reference lot.The donor samples of both lots showed comparable results.We have not observed any weakening of antigenicity.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot the customer returned the complaint sample ih-cell a1&b for investigational testing but at the time we received it, it was already expired.Additionally, the customer returned four patient samples labeled as #(b)(4) (plasma and red blood cells separated in each case).Testing of the patient samples is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported false negative reactions of two patient samples with ih-cell a1.Both patient samples had blood group b.Because the complaint sample was not available for investigation within its shelf life, our quality control laboratory tested their retention sample of the supposedly defective lot.Different donor samples were manually tested in parallel with a reference lot.All positive and negative reactions were correct.We did not observe any false negative reaction.Additionally, the donors of the supposedly defective lot were tested for potency in parallel with the reference lot.The donor samples of both lots showed comparable results.We have not observed any weakening of antigenicity.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot the customer returned the complaint sample ih-cell a1&b for investigational testing but at the time we received it, it was already expired.Additionally, the customer returned four patient samples labeled as (b)(6), (b)(6)(plasma and red blood cells separated in each case).When we received the patient material, the samples were tested manually with the current lots of ih-cell a1&b and ih-card abo/d(dvi-) +rev.A1, b.The centrifugation and reading of the results were performed on the ih-reader 24.The blood group b of patient sample #(b)(6) was confirmed.The reaction with ihcell a1 was weak positive.The second patient sample (b)(6) showed blood group a and not b.The reverse grouping could not be performed, because there were returned only red blood cells and no plasma or serum.The isoagglutinin titer of patient sample (b)(6) was determined by tube test in comparison to three other known b donor plasmas.Patient sample (b)(6) showed a titer of 1 in the immediate spin test and in the tube test with an incubation of 15 minutes at room temperature, while the three known donor samples showed titers of 2, 4 and 8.In the test method 30 minutes at 2 to 8°c the patient sample 3454773 showed a titer of 2, while the three known donor samples showed titers of 4 and 8.Based on the investigation the complaint was classified as confirmed - epp (expected product performance): the complaint sample could not be tested within shelf life and the retention sample reacted as expected.The potency testing of the retention sample of the supposedly defective lot did not show any weakening of the antigenicity.The potency testing of the patient plasma (b)(6) confirmed a weakening of the isoagglutinin anti-a1.Here, we would like to refer to the chapter limitations of the ifu (instruction for use), where it is stated: "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." the second patient sample (#(b)(6) contained only red blood cells and no plasma :it did not show blood group b as communicated but blood group a.

• 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: 15709685
• Report Number: 9610824-2022-00066
• Device Sequence Number: 4972316
• Product Code: QHT
• UDI-Device Identifier: 07611969952243
• UDI-Public: (01)07611969952243(17)221024(10)9234021
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/12/2022

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: 10/24/2022
• Device Catalogue Number: 814010100
• Device Lot Number: 9234021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 12/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IH-CARD ABO/D(DVI-)+REVA1,B, LOT 9145030; IH-CARD ABO/D(DVI-)+REVA1,B, LOT 9145030
• Patient Sex: Unknown