MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK 2 AST-GP68 TEST KIT; VITEK® 2 AST-GP68 TEST KIT

Catalog Number	22231
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of obtaining terminated results and observing tape wrinkles on multiple cards in association with the vitek® 2 ast-gp68 test kit (ref 22231, lot 1331246403).The customer also stated that the cards gave terminated (trm) results and results were delayed > 24 hours.The customer then opened additional pouches to examine cards and found at least 10 cards with a film defect.The number of patient samples for which delays occurred due to the tape defect and trm results was not disclosed by the customer.There is no indication or report from the customer that the delay led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This investigation was initiated in response to a customer complaint reporting top-tape defects for seven (7) vitek® 2 ast-gp68 cards associated with lot 1331246403.The customer additionally indicated that one card terminated during testing at 17.78 hour for streptococcus pneumoniae.No cards were returned by the customer for investigation.Photographs of the seven (7) implicated cards were provided by the customer.These cards exhibited a tape tear at the right edge of the top-tape.The tear on the top-tape was likely caused by tape/adhesive buildup in an area of minimal clearance during the manufacturing process, although the root cause could not be determined based on the photographs alone.The card and the manufacturing process are both designed in such a way that the taped surface of the card is rarely contacted during manufacturing.After the tape is applied to the card, the taped surface of the card does not get contacted.It is likely that the transfer tube of a card was beneath the bottom right corner of the card when it was fed into the pouching operation at poucher 5.This raised the lower right corner of the card so that it contacted a beveled block at the pouch infeed, an area of lesser clearance.When the card contacted the block, tape/adhesive buildup was left behind.The tape/adhesive buildup contacted subsequent cards causing tape tears at the right edge of the tape.The tape/adhesive debris dislodged itself on a subsequent card.All impacted cards (for which photos were provided) were pouched at 0701 on 26oct2019.It is likely that only a small portion of cards are impacted.There have been no other complaints against the lot that were associated with tape tears.Ast-gn68 lot 1331246403 was manufactured on 25oct2019, with an expiration of 25apr2021.Since the manufacture of the lot, the beveled block has been removed from all pouching equipment.This location is no longer an area of lesser clearance.With the block removed, the opportunity to create this defect in this location no longer exists.

• Brand Name: VITEK 2 AST-GP68 TEST KIT
• Common Device Name: VITEK® 2 AST-GP68 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11101856
• Report Number: 1950204-2020-00225
• Device Sequence Number: 3847553
• Product Code: LON
• UDI-Device Identifier: 03573026245573
• UDI-Public: 03573026245573
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 04/25/2021
• Device Catalogue Number: 22231
• Device Lot Number: 1331246403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1