MAUDE Adverse Event Report: MICROTYPING SYSTEMS MTS A/B/D/A/B/D MONO GRP 5X20; MTS GEL CARDS - BLOOD GROUPING REAGENTS

Catalog Number	MTS081115
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation details: the customer stated that all quality control (qc) testing on the day of use was performed and was acceptable.(no further details provided).The customer states all products were stored as per ortho instructions for use (ifu) and all products passed visual inspection prior to use with no defects found.The customer states visual inspection of the mts gel cards, and reagent red cells was performed and was acceptable prior to use.Quality control and donor segment testing result reports were requested for review but not provided.Additional details regarding the original event were requested, but not provided.Mts diluent 2 plus lot information and use information was requested, but not provided.As part of the investigation, a batch record review of the mts abd monoclonal grouping gel card lot was reviewed, and no discrepancies were discovered.All in-process and final release serological testing results were within specifications, including customer use ortho vision testing results.All qc inspection records (packaging and gel card inspection documents) of this product lot indicated acceptable results; no gel card defects were identified during qc inspection.All id-mts gel cards used during in-process qc testing passed the visual check performed by the serologist.Formulation stage batch records (anti-b lot 080823040 and anti- d lot 080823041) associated with this id-mts gel card lot were reviewed and no discrepancies were discovered.The equipment area use log used during production of this lot was reviewed and a stop was documented for bent needles.Needles were changed and production continued.There were no product nonconformances related to this lot.The lot met all specifications, all in-process and product release criteria.(dra605916) additionally, retains testing of mts abd monoclonal grouping card lot 081823053-02, expiry 22may2024, was requested.The investigation identified that mts a/b/d monoclonal grouping card lot#081823053-02 performed as intended.Mts a/b/d monoclonal grouping card lot#081823053-02 retention cards were tested by manual method with mts diluent 2 plus lot#mdp230, albaq-chek lot#v27010 and donor:711562 (o neg).All results were as expected.A total of 100 retention cards were visually inspected and no defects were found.No customer return cards received by mts.Product testing with retain cards performed as intended.No discrepant results obtained with albaq-chek and donor samples.Unable to confirm customer complaint as mts a/b/d monoclonal grouping card lot#081823053-02 performed as intended.(dra605917) as well, a query of the worldwide complaint databases was performed for mts gel card lot 081823053-02 through 18apr2024.No additional complaints were observed against the sublot for the failure mode.The one complaint for falsepos was identified.For thoroughness, a review of the mother bulk lot, 081823053, was also performed.One additional complaint was identified for a different sublot for a related call area, ind.No trends by sublot or mother bulk were identified for falsepos or related call areas.(dra605918) no further investigation was performed on this incident.The potential assignable cause of the discordant positive anti-b and anti-d column reactions of the abo monoclonal grouping testing for two donor unit segments is unknown.There was no evidence of any systematic failure of ortho reagents to perform as intended.No further complaints of this type have been received from the customer since the time of the reported events.
Event or Problem Description
Report 2 of 2 cms 2609581 windchill ra605915 complaint description: on (b)(6) 024, a customer contacted the global technical solutions center (gtsc) to report false positive results for the anti-b and anti-d columns for abo forward grouping testing of two known o negative donor units in mts abd monoclonal grouping card lot 081823053-02 (expiry 22may2024) using manual gel technique.Complainant: (b)(6) (medical technologist) (b)(6) 62276 date of events: original date requested, but not provided and 01apr2024; reported 01apr2024.Reagents: mts abd monoclonal grouping gel card lot 081823053-02 (expiry: 22may2024) mts 2 plus diluent (lot information requested but not provided) sample information: 2 donor segments - expected o neg sample ids requested but not provided.The customer stated that on (b)(6) 2024, one donor unit segment was tested for abo using abd monoclonal grouping gel card lot 081823053-02.The unit sample produced unexpected positive 3+ reactions in the anti-b and anti-d columns of the gel card.The customer states that the week prior, a similar event also occurred with false positive 3+ reactions in both the anti-b and anti-d columns for one o negative donor utilizing the same mts gel card lot.(the specific date of the event was requested, but not provided, and no further details were given.Prior event was not previously reported to ortho.) on the same day, the customer states they repeated testing of the donor segments in both manual gel technique with the same lot of mts gel cards and in tube method and expected results were obtained.(no further details provided).No biased results were reported to the physicians.No units were transfused prior to repeat testing completion.No donors or patients were harmed because of these events.

• Brand Name: MTS A/B/D/A/B/D MONO GRP 5X20
• Common Device Name: MTS GEL CARDS - BLOOD GROUPING REAGENTS
• Manufacturer (Section D): MICROTYPING SYSTEMS; 1295 s.w. 29th avenue; pompano beach FL 33069
• Manufacturer (Section G): MICROTYPING SYSTEMS; 1295 s.w. 29th avenue; pompano beach FL 33069
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19181135
• Report Number: 1056600-2024-00003
• Device Sequence Number: 7412369
• Product Code: QHR
• UDI-Device Identifier: 10758750005963
• UDI-Public: 10758750005963
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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 Catalogue Number: MTS081115
• Device Lot Number: 081823053-02
• 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: 04/01/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown