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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false positive reactions with ih-cell a1&b in the reverse typing on their ih-500 instrument.The customer stated that they repeated all samples in the tube test and the reactions were correctly negative.The customer did not yet return the complaint sample ih-cell a1&b for investigational testing but announced the shipment of the complaint sample and patient samples.In the meantime, our quality control tested their retention sample of the supposedly defective lot with donor samples on the ih-500.All positive and negative reactions were correct.We did not observe any false positive reaction with ih-cell a1&b.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.We requested instrument data and images of the affected ih-500 instrument, the investigation is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported false positive reactions with ih-cell a1&b in the reverse typing on their ih-500 instrument.The customer stated that they repeated all samples in the tube test and the reactions were correctly negative.The customer had announced to send in a product sample.While our quality control laboratory was waiting for the material of the customer to arrive, they tested their retention sample of the supposedly defective lot with donor samples on the ih-500.All positive and negative reactions were correct.We did not observe any false positive reaction with ih-cell a1&b.The customer returned a sample of the affected product ih-cell a1&b for investigational testing, the test results of six discrepant blood group typing and four patient samples labeled as (b)(6).The patient samples were separated in plasma and red blood cells.The red blood cells were completely hemolyzed and therefore could not be used for any tests.At the time we received the product sample returned by the customer, the reagent red blood cell lot ih-cell a1&b was already expired.The customer returned three different packages of ih-cell a1&b.All three packages had been opened, had different volumes left and were opened at different points in time.The customer sent the result protocols of 6 discrepant blood group determinations, but only 4 corresponding blood samples.Furthermore, the customer sent 3 packages of the allegedly defective product ih-cell a1&b lot 9322011.The returned vials showed different usage of the material and were opened at different dates as showed handwritten dates on the labels: (b)(6) 2023.It was noticeable here that the vials opened on (b)(6) 2023 showed the strongest brown discoloration/hemolysis.The vials opened on (b)(6) 2023 also showed brown discoloration/hemolysis, but less pronounced than those opened first.The vials opened last also already showed incipient hemolysis, but no brown discoloration yet.The patient samples sent in by the customer were initially tested with ih-cell a1&b lot 9334021 currently in use.Since the patient red blood cells were completely hemolyzed and could not be used, the testing was performed in the manual method, as testing with the ih-500 requires red blood cells as well as plasma.Additionally, despite reaching its expiration date, the retention sample of the allegedly defective lot of ih-cell a1&b was used.An antibody screening was perfomred in different testing methods and temperatures (cold and room temperature, 37 degrees celsius, iat) and yielded consistently negative reactions.Because of these negative reactions, the reagent red blood cells provided by the customer, which were visually found unsuitable for use, were used for testing.Here, false positive reactions were obtained with the vials opened on (b)(6).No false positive reactions were obtained when using the vial opened on (b)(6) 2023.Because of the non-specificities, all vials provided by the customer as well as our qc laboratory's retention sample were sent to an external laboratory for bioburden testing.All bioburden tests were negative; no microbiological growth was detected in any of the samples.The affected ih-500 instrument processed all tests the customer filed his complaint for as per system specifications, there was no error during the processing time.Splashes in the incubation chamber or dried gel could be possible a root cause of the discrepancy.No images were provided along with the trace files; therefore it was not possible to determine if there were any defect in the cards or reagent vials used to perform those tests.As the reagent vials share the same barcode and have been loaded/unloaded several times in the period of the tests the customer complained, it was not possible to trace back a vial across several tests and confirm the issue is related to a single vial.With the data available to us, no instrument malfunction could be identified.Based on the investigation the complaint was classified as undetermined.The three packages the customer provided could not be tested within their shelf life and the retention sample reacted as expected.No antibodies were detected in the four patient samples provided by customer.False positive reactions of the patient samples could only be observed in two of the three packages returned by the customer.These false positive reactions occurred only with the kits that also showed brown discoloration and hemolysis.The third kit, which was also expired at the time of our testing, showed light, incipient hemolysis and correct reactions with the patient samples.The cause of the false positive reactions at the customer's site remains unknown.It was also unclear whether there was a correlation between the occurrence of discolorations and false positive reactions.A general issue of the lot can be excluded, because both the retention sample and one of the three customer packages showed correct results.Furthermore, both the customer's packages and the retention sample had a negative bioburden test.No microbiological growth was detected in any of the samples.With the data available, no instrument malfunction could be identified.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 Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 17601477
• Report Number: 9610824-2023-00050
• Device Sequence Number: 6139193
• Product Code: QHT
• UDI-Device Identifier: 07611969952243
• UDI-Public: (01)07611969952243(17)230731(10)9322011
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 11/02/2023

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: 07/31/2023
• Device Catalogue Number: 814010100
• Device Lot Number: 9322011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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-500, SN (B)(6); IH-500, SN (B)(6)
• Patient Sex: Unknown