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	07/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that two samples from two different patients were negative using ih-cell a1&b on ih-1000 but strong (3-4+) using manual tube method.The customer specified that the reactions with ih-cell b of ih-cell a1&b were false negative.The customer stated that repeat testing using the same instrument and manual methods reproduced the same results.Furthermore; the customer stated that the samples were sent to another lab in the same group.The reverse typing was positive for both samples on the ih-500.The reaction strength with ih-cell b was 2+ positive on the ih-500.The customer did neither return a productt sample for investgational testing nor the patient samples that caused the false negative test results.Therefore; our quality control laboratory tested their retention sample.First, the quality control laboratory tested the retention sample with several donor samples (7x blood group a, 7x blood group o and 2x blood group b).The testing was performed on ih-1000, ih-500 and manually.All positive and negative reactions were correct and comparable.We did not observe any false negative reaction.Then, our quality control laboratory tested the donor samples with further lots of ih-cell a1&b.Again, all positive and negative reactions were correct and the results within the different lots were comparable.Furthermore, the retention sample of the supposedly defective lot was tested for potency in the tube technique.The testing was performed in parallel with the other lots of ih-cell b and with different known weak reacting isoagglutinins.The results showed that the positive reactions in the tube test were stronger than in the ih-system and that the antigenicity of the claimed ih-cell b was not weakened.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Regrding the affected ih-1000, databases and log files have been received and are analyzied for any issue relevant anormalies.This investigation is still ongoing.
Event or Problem Description
The customer reported that two samples from two different patients were negative using ih-cell a1&b on ih-1000 but strong (3-4+) using the manual tube method.The customer specified that the reactions with ih-cell b of ih-cell a1&b were false negative.He stated that repeat testing using the same instrument and manual method reproduced the same results.Furthermore, the customer stated that the samples were sent to another lab in the same group.The reverse typing was positive for both samples on the ih-500.The reaction strength with ih-cell b was 2+ positive on the ih-500.The customer did neither return a product sample for investgational testing nor the patient samples that caused the false negative test results.Therefore, our quality control laboratory tested their retention sample.First, the quality control laboratory tested the retention sample with several donor samples (7x blood group a, 7x blood group o and 2x blood group b).The testing was performed on ih-1000, ih-500 and manually.All positive and negative reactions were correct and comparable.We did not observe any false negative reaction.Then, our quality control laboratory tested the donor samples with further lots of ih-cell a1&b.Again, all positive and negative reactions were correct and the results within the different lots were comparable.Furthermore, the retention sample of the supposedly defective lot was tested for potency in the tube technique.The testing was performed in parallel with the other lots of ih-cell b and with different known weak reacting isoagglutinins.The results showed that the positive reactions in the tube test were stronger than in the ih-system and that the antigenicity of the claimed ih-cell b was not weakened.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Trace files of the affected ih-1000 were analyzed for any issue relevant anormalies.Our investgation showed that the distribution sequence was correctly performed, and the volume dispensed (serum + cells) on the well b and a1 are in the range.The camera and the reading module were correctly adjusted.Based on the investigation the complaint was classified as undetermined.The complaint sample was not available for investigation and the retention sample reacted as expected.Comparative and potency tests demonstrated that the antigenicity of the claimed ih-cell b was not weakened.The analysis of the instrument data did not give any indication of a malfunction of the instrument.Samples of the two affected patients were not available for testing.However, 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.".
Additional Manufacturer Narrative
This is our final report on this incident.

• 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: 15143714
• Report Number: 9610824-2022-00041
• Device Sequence Number: 5529611
• Product Code: QHT
• UDI-Device Identifier: 07611969952243
• UDI-Public: (01)07611969952243(17)220801(10)9222011
• 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): 02/22/2023

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: 08/01/2022
• Device Catalogue Number: 814010100
• Device Lot Number: 9222011
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 02/22/2023
• 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-500; IH-500; IH-CARD ABO/D(DVI-)+REVA1,B, LOT 9204010; IH-CARD ABO/D(DVI-)+REVA1,B, LOT 9204010
• Patient Sex: Unknown