MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-05-05 for ETEST? DAPTOMYCIN DPC 256 WW S30 412324 manufactured by Biomerieux, Sa.
[44564813]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[44564814]
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.
Patient Sequence No: 1, Text Type: D, B5
[54921746]
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. Biom? Rieux 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 biom? Rieux 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00086 |
| MDR Report Key | 5635300 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-05 |
| Date of Report | 2016-04-27 |
| Date Mfgr Received | 2016-04-27 |
| Device Manufacturer Date | 2015-06-18 |
| Date Added to Maude | 2016-05-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME LES GROTTES ISERE, 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETEST? DAPTOMYCIN DPC 256 WW S30 |
| Generic Name | ETEST? DAPTOMYCIN |
| Product Code | JWY |
| Date Received | 2016-05-05 |
| Catalog Number | 412324 |
| Lot Number | 1004093520 |
| Device Expiration Date | 2018-06-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, SA |
| Manufacturer Address | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE, 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-05 |