MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PANEL PHOENIX NMIC-306; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number 449292

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that while using panel phoenix nmic-306 a false ertapenem resistance was observed by the laboratory personnel.Multiple attempts have been made to obtain additional information, with no response from the customer at this time.

Manufacturer Narrative

Investigation summary: this complaint investigation is only applicable to us panel formats only.This complaint is due to false resistance of ertapenem when using phoenix panel nmic-306 (449292) batch number unknown.No material batch number, lab reports, product returns or isolates were provided for investigation.Since the batch number was not provided, four (4) retention panels from a different batch (#0148033) were tested using a phoenix 100 instrument.One (1) panel was tested with an in house isolate of klebsiella pneumoniae 11001, one (1) panel was tested with an in house isolate of enterobacter cloacae 11061, one (1) panel was tested with an in house isolate of escherichia coli 13293 and the final one (1) panel was tested with an in house isolate of klebsiella aerogenes a13048.All panels yielded the correct mic (= 0.25) for sensitive ertapenem results.This complaint is not confirmed.A review of quality notifications was unable to be performed as no batch number was provided.A review of prior complaints was unable to be performed as no batch number was provided.Complaint trending was performed and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.

Event Description

It was reported that while using panel phoenix nmic-306 a false ertapenem resistance was observed by the laboratory personnel.Multiple attempts have been made to obtain additional information, with no response from the customer at this time.

• Brand Name: PANEL PHOENIX NMIC-306
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11374560
• MDR Text Key: 242644202
• Report Number: 1119779-2021-00382
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

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
• Device Operator: Other
• Device Catalogue Number: 449292
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1