MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-13 for NEG BREAKPOINT COMBO 47 N/A B1017-417 manufactured by Beckman Coulter.
[5698590]
The customer reported obtaining two different biotypes for the non-lactose fermenter organism in a proficiency survey stool specimen on the walkaway (wa) 40si instrument using negative breakpoint combo 47 panel type. The isolate in question was identified as d-04 2015 cap survey isolate. Identification (id) of leminorella sp. 93. 14% on initial test and upon retest, shigella sp. 99. 30% was attained. The only difference reported between the two panels was the cephalothin (cf8) well, which was positive on the initial test and negative on the repeat panel. Another repeat, date was unknown but believed to be on or around (b)(6) 2015 resulted in an id of leminorella 93% there was no patient involved as this was a proficiency survey isolate.
Patient Sequence No: 1, Text Type: D, B5
[13004269]
The manufacturer participated in the same proficiency survey using d-04 2015 cap survey isolate. When tested on conventional overnight panels and read on the wa instrument, an id of leminorella sp. 93. 14% was attained. When the same panel was read on the autoscan-4 (as-4) instrument, an id of shigella sp. 99. 30% was attained. The difference between the two reads was the cf8 well; the cf8 well was negative on the wa and positive on the as-4. It was noted that the cf8 well was a weak positive when visually verified. An id of shigella was also attained on two additional tests using rapid negative panels. Also, the sample was tested on an analytical profile index (api) strip as a reference test method. A low probability id of shigella sp. Was attained. Please refer to medwatch report number 2919016-2015-00008 for a report of a similar event which occurred on (b)(6) 2015. Mdr numbers 2919016-2015-00006 and 2919016-2015-00007 were filed for the id discrepancy observed during internal testing. The cap proficiency survey report is still outstanding for this isolate, therefore unable to confirm correct id of the organism. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30231639]
The cap survey was received confirming the identification of the(b)(6) isolate as shigella boydii.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2015-00009 |
| MDR Report Key | 4601662 |
| Report Source | 05,06 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-02-25 |
| Date of Event | 2015-02-25 |
| Date Mfgr Received | 2015-03-26 |
| Device Manufacturer Date | 2014-11-14 |
| Date Added to Maude | 2015-04-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NORMA RAHILL |
| Manufacturer Street | 1584 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163742139 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95691 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEG BREAKPOINT COMBO 47 |
| Generic Name | MICRO DILUTION PANEL |
| Product Code | LTT |
| Date Received | 2015-03-13 |
| Model Number | N/A |
| Catalog Number | B1017-417 |
| Lot Number | 2015-11-14 |
| Device Expiration Date | 2015-11-14 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-13 |