MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL-I 11 PLUS

Catalog Number	816022100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant antibody detection results and false negative results on one patient using biotestcell i11-plus on tango infinity.One patient sample (b)(6) was tested on (b)(6) 2024 on the tango infinity with biotestcell 3, lot 9429011-00.The test result was: p1 was edited from +/- to 1+, p2 = 1+, p3 was negative.The same sample was tested using the same instrument on the same day with biotestcell-i11 plus.The test result showed that cells 1 - 3 were +/- but edited to 1+.The customer noted that cell 4 appeared to be positive but was interpreted as negative by the instrument.We were informed that the patient received rhogam during the 1st week of (b)(6) 2024.The retention sample of the complained product biotestcell i11-plus was tested during its shelf-life.Biotestcell-i 11 plus, lot 9430011-00 was tested with 4 known antibodies (anti-c, anti-fya, anti-k (determined in double) and solidscreen ii control).Also, 3 donor samples supposed to be antibody free were tested and additionally solidscreen ii negative control.All test results were within expectations.The tests carried out in double determination achieved the same test results (+/- 1 reaction strength) when testing the positive antibodies.The donor samples as well as the solidscreen ii negative control reacted negatively.The positive control solidscreen ii control (anti-d) reacted clearly positive.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Log files of the affected tango infinity instrument are currently under investigation.This medical device report is not submitted within the required 30-day period.We deeply regret this omission.An internal quality notification, qn (b)(4), has been opened for this reason.
Additional Manufacturer Narrative
This is our initial report on this incident.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported discrepant antibody detection results and false negative results on one patient using biotestcell i11-plus on tango infinity.One patient sample (b)(6) was tested on (b)(6) 2024 on the tango infinity with biotestcell 3, lot 9429011-00.The test result was: p1 was edited from +/- to 1+, p2 = 1+, p3 was negative.The same sample was tested using the same instrument on the same day with biotestcell-i11 plus.The test result showed that cells 1 - 3 were +/- but edited to 1+.The customer noted that cell 4 appeared to be positive but was interpreted as negative by the instrument.We were informed that the patient received rhogam during the 1st week of (b)(6).The retention sample of the complained product biotestcell i11-plus was tested during its shelf-life.Biotestcell-i 11 plus, lot 9430011-00 was tested with 4 known antibodies (anti-c, anti-fya, anti-k (determined in double) and solidscreen ii control).Also, 3 donor samples supposed to be antibody free were tested and additionally solidscreen ii negative control.All test results were within expectations.The tests carried out in double determination achieved the same test results (+/- 1 reaction strength) when testing the positive antibodies.The donor samples as well as the solidscreen ii negative control reacted negatively.The positive control solidscreen ii control (anti-d) reacted clearly positive.A product sample of the allegedly defective lot of biotestcell i11-plus was requested from the customer for investigational testing as well as the patient sample that had caused the false negative result.Neither product nor patient sampel were provided, therefore an expedient investigation was not possible.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Log files of the affected tango infinity instrument showed no indication of an instrument malfunction.It can be assumed that decreasing and weak reactivity of the passive anti-d may have led to a certain degree of variability.The reactions in the first test run were already weak, which also indicates that the rhogam is present at a limit concentration that can lead to different reaction strengths, as each method used has its variation.We referred the customer to the note in our ifu under "limitations": "negative reactions will be obtained if the sample contains antibodies present in concentrations too low to be detected by the test method employed.No test method is capable of detecting all red cell antibodies." this medical device report is not submitted within the required 30-day period.We deeply regret this omission.An internal quality notification, qn (b)(4), has been opened for this reason.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL-I 11 PLUS
• Common Device Name: BIOTESTCELL-I 11 PLUS
• 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: 20299279
• Report Number: 9610824-2024-00043
• Device Sequence Number: 18078958
• Product Code: QHT
• UDI-Device Identifier: 07611969952441
• UDI-Public: (01)07611969952441(17)240923(10)9430011-00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 125207
• 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): 10/30/2024

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: 09/23/2024
• Device Catalogue Number: 816022100
• Device Lot Number: 9430011-00
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/30/2024
• 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: BIOTESTCELL 3, LOT 9429011-00; BIOTESTCELL 3, LOT 9429011-00; TANGO INFINITY, SN (B)(6); TANGO INFINITY, SN (B)(6)
• Patient Sex: Unknown