MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® DAPTOMYCIN DPC 256 WW S30

Catalog Number	412324
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
A customer in (b)(6) reported a daptomycin qc (atcc 9212 tm) failure oorl (out of range low) for enterococcus faecalis when tested with the etest daptomycin kit.Expected mic value is 1 - 4 ml; results obtained were 0.5 ml and 0.75 ml.There is no indication or report from the hospital to biomerieux that the daptomycin qc failure led to any adverse event related to a patient's state of health.There is no patient directly associated with the qc sample.Culture submittals have been requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification that a customer in (b)(6) reported occurrence of a low mic result for enterococcus faecalis atcc® 29212¿ in association with the etest® daptomycin kit.Biomérieux investigation was conducted.Expected values: 1-4 ug/ml.Customer results: between (b)(6) 2016, four (4) results at 0.5 ug/ml on twelve (12) data.Four (4) data at 0.75 ug/ml are acceptable - instruction for use 9302553c indicates: an etest® mic value which falls between standard two-fold dilutions must be rounded up to the next upper two-fold value before categorization.The customer did not submit test strips for investigational testing.Retained samples (customer batches 1004340160 and 1004093520) were tested, in parallel with another batch as reference.The investigation did not reproduce the issue observed by the customer with the quality control strains.The conformity of this batch was confirmed with three (3) qc atcc® strains: atcc® 29212¿ enterococcus faecalis, atcc® 29213¿ staphylococcus aureus and atcc® 49619¿ streptococcus pneumoniae.The investigation concluded the etest® daptomycin kit is performing as intended.As the customer product was not submitted for internal biomérieux testing, it can be hypothesized: media: as explained in cis 014 or 9302553c, daptomycin requires physiologic levels of calcium (ca2+) for expression of adequate activity.The bioavailable free ca2+ levels in brands and batches of mha powder and commercial mha plates can vary significantly and affect etest® dpc results.Use only mha plates with consistent and appropriate ca2+ levels (25-40 ug/ml).Perform quality control (qc) using both enterococcus faecalis atcc® 29212¿ (1-4) and staphylococcus aureus atcc® 29213¿ (0.25-1 [ ug/ml).Use of two qc strains allows verification of results within the susceptible range and around the breakpoint.When results are out of qc specifications or consistently skewed at the limits, repeat the test using a different brand of mha.Reading: the investigation observed microcolonies with enterococcus faecalis atcc® 29212¿.Read different etest® mic endpoint patterns using the etest® reading guidelines = (b)(4) in this case, read where the microcolonies are inhibited.

• Brand Name: ETEST® DAPTOMYCIN DPC 256 WW S30
• Common Device Name: ETEST® DAPTOMYCIN
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• MDR Report Key: 5635300
• Report Number: 3002769706-2016-00086
• Device Sequence Number: 499073
• Product Code: JWY
• Combination Product (Y/N): N
• PMA/510(K) Number: K042392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2016

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: 06/17/2018
• Device Catalogue Number: 412324
• Device Lot Number: 1004093520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2016
• Supplement Report FDA Received Date: 08/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1