MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[39484565]
The investigation determined that lower than expected vitros gent and vanc quality control results were obtained from two different lots of vitros tdm pv3 controls on a vitros 5600 integrated system. The assignable cause of the event is unknown. An instrument issue cannot be ruled out. The customer performed maintenance on the instrument changing the photometer lamp, metering proboscis and recalibrated using fresh reagent packs. Following these maintenance actions, acceptable gent and vanc quality control results were observed. However, a pre-maintenance vitros within-run precision test was not performed; therefore, an instrument related issue cannot be ruled out. No direct evidence of a reagent issue could be confirmed or ruled out as a contributor to the event. Finally, improper pre-analytical sample handling of the vitros tdm pv fluids cannot be ruled out as a possible contributing factor. The assignable cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[39484566]
A customer observed multiple lower than expected vitros vanc and vitros gent quality control results on two different lots of vitros tdm pv3 controls on a vitros 5600 integrated system. (b)(6). Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected. No patient samples were processed during the timeframe the quality control results were unacceptable, however, the investigation could not confirm that patient samples would not be affected if the event were to recur undetected. There was no allegation of actual patient harm as a result of this event. This report is number two of four mdr's for this event. Four 3500a forms are being submitted for this event as four devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2016-00004 |
| MDR Report Key | 5462712 |
| Date Received | 2016-02-26 |
| Date of Report | 2016-02-26 |
| Date of Event | 2016-01-28 |
| Date Mfgr Received | 2015-12-15 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2016-02-26 |
| 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. 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 | 2016-02-26 |
| Catalog Number | 6801711 |
| Lot Number | 1512-10-4719 |
| Device Expiration Date | 2017-07-01 |
| 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 | 2016-02-26 |