MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-18 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[60760694]
The investigation determined that higher and lower than expected vitros gent quality control results were obtained from a non-vitros biorad l2 control fluid tested on a vitros 4600 chemistry system the assignable cause of the event is unknown, however pre-analytical reagent pack handling variability cannot be ruled out as contributing to the event. The customer decided to put a consistent vitros gent reagent pack handling protocol in place, and then monitor gent performance. No analyzer malfunction was identified as within run precision testing was within the expected guidelines, indicating the vitros 4600 system was performing as intended. The assignable cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[60760695]
A customer observed lower and higher than expected vitros gent quality control results obtained from a non-vitros biorad l2 control fluid when tested on a vitros 4600 chemistry system. Biorad l2: results of 9. 31, 2. 27, 2. 43, 2. 93, 3. 24, 2. 84, 3. 72, and 3. 64 ug/ml vs. The expected result of 5. 40 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected. There was no report of affected patient samples, however; the investigation cannot conclude that patient sample results had not been affected or 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 three 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 | 1319808-2016-00027 |
| MDR Report Key | 6111974 |
| Date Received | 2016-11-18 |
| Date of Report | 2016-11-18 |
| Date of Event | 2016-09-03 |
| Date Mfgr Received | 2016-10-26 |
| Device Manufacturer Date | 2015-10-19 |
| Date Added to Maude | 2016-11-18 |
| 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 | 2016-11-18 |
| 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 | 2016-11-18 |