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 2016-11-07 for VITEK? 2 ANC ID TEST KIT 21347 manufactured by Biomerieux, Inc.
[59348920]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[59348921]
A customer in (b)(6) contacted biom? Rieux to report a misidentification of atcc baa 1296 bacteroides ovatus as fusobacterium mortiferum in association with the vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit. The customer also tested a replacement atcc baa 1296 bacteroides ovatus strain and obtained incorrect results. The customer obtained a new frozen cryobead strain; testing via vitek 2 anc id card achieved the expected result of bacteroides ovatus. The customer stated they have a mass spectrometer, and the discrepant vitek 2 anc id results had no adverse impact to any patient's state of health. The atcc baa 1296 bacteroides ovatus strain was not directly related to any patient. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[63730431]
A customer in (b)(6) contacted biom? Rieux to report a misidentification of atcc? Baa 1296? Bacteroides ovatus as fusobacterium mortiferum in association with the vitek? 2 anaerobic and corynebacteria (anc) identification (id) test kit. A biom? Rieux internal investigation was performed. The customer reported using all required set ups for anc qc testing; however, their original strain was stored at -24c when storage at -70c is recommended. A strain was obtained from another source and tested from the appropriate medium; however, a 48-hour culture was used when the age of culture should be 18-24 hrs. The strain was unidentified. The strain was then obtained from a new frozen cryobead and correct results were obtained. Eight (8) lab reports were submitted. Results are listed by date of testing. On (b)(6) 2016: unidentified organism with six (6) incorrect qc reactions (5/6 were expected positives reporting as negative). On (b)(6) 2016: unidentified organism with five (5) incorrect qc reactions (5/5 were expected positives reporting as negative). On (b)(6) 2016 (#1): fusobacterium mortiferum with six (6) incorrect qc reactions (6/6 were expected positives reporting as negative). On (b)(6) 2016 (#2): unidentified organism with five (5) incorrect qc reactions (5/5 were expected positives reporting as negative). On (b)(6) 2016: unidentified organism with 14 incorrect qc reactions (10/14 were expected positives reporting as negative). On (b)(6) 2016: bacteroides ovatus with three (3) incorrect qc reactions (3/3 were expected positives reporting as negative). On (b)(6) 2016: low discrimination result with bacteroides ovatus and 13 incorrect qc reactions (13/13 were expected positives reporting as negative). On (b)(6) 2016: bacteroides ovatus with all qc reactions correct. An increased number of atypical negative results can indicate a strain with decreased viability or user set up error, improper storage of the strain or environmental conditions were not sufficient to properly grow this anaerobic qc strain. Without the strain or raw data it's not possible to further evaluate the cause of the mis-identification. On 11nov2016 industrialization-anc lot 244386840 and 244394540 met final qc release criteria. There were no issues observed on initial qc performance testing. No further action deemed necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00167 |
| MDR Report Key | 6083972 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-07 |
| Date of Report | 2016-10-11 |
| Date Mfgr Received | 2016-10-11 |
| Device Manufacturer Date | 2016-03-02 |
| Date Added to Maude | 2016-11-07 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK? 2 ANC ID TEST KIT |
| Generic Name | VITEK? 2 ANC ID TEST KIT |
| Product Code | JSP |
| Date Received | 2016-11-07 |
| Catalog Number | 21347 |
| Lot Number | 244386840 |
| Device Expiration Date | 2017-07-17 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC |
| Manufacturer Address | 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-07 |