MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-30 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[27252304]
The investigation determined that multiple lower than expected vitros gent proficiency results on a vitros 5,1 fs system. The investigation was unable to determine a definitive root cause. The most likely assignable cause of this event was user protocol error with respect to reagent pack handling. In addition, the vitros 5,1 system performance cannot be completely ruled out as a contributing factor.
Patient Sequence No: 1, Text Type: N, H10
[27252325]
A customer observed lower than expected vitros gent results from 5 different proficiency sample fluids processed on a vitros 5,1 fs system. Vitros gent proficiency results: (b)(6). The customer made no allegations that patient sample results were affected. However, biased patient results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected. There was no allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2015-00018 |
| MDR Report Key | 5114991 |
| Date Received | 2015-09-30 |
| Date of Report | 2015-09-30 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2015-09-02 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2015-09-30 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS GENT REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LCD |
| Date Received | 2015-09-30 |
| Catalog Number | 6801711 |
| Lot Number | 1512-09-3511 |
| Device Expiration Date | 2015-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-30 |