MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-11-27 for PREVI? COLOR GRAM 29551R manufactured by Biomerieux, Sa.
[129580608]
A customer in the united states contacted biom? Rieux to report observing crystals in the gram stains prepared by the previ? Color gram instrument. The customer stated the crystals look like gram negative rods, and have caused some laboratory technicians to misinterpret the result. Manual gram staining does not create the reported effect. The customer stated there have been a few incidences of calling gram negative rods (gnrs) on spinal fluids. These situations cause a delay (duration not disclosed) due to further testing via manual staining. The customer stated there have been no treatment decisions by a physician based on a discrepant gram stain result. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00245 |
| MDR Report Key | 8105626 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-27 |
| Date Mfgr Received | 2018-10-28 |
| Date Added to Maude | 2018-11-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| 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 | PREVI? COLOR GRAM |
| Generic Name | PREVI? COLOR GRAM |
| Product Code | KPA |
| Date Received | 2018-11-27 |
| Model Number | 29551R |
| 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 | 2018-11-27 |