MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-19 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[4849464]
The customer observed lower than expected vitros gent results on three different quality control fluids processed on a vitros 5,1fs chemistry system using vitros gent reagent, lot 1512-09-3511. Tdm lev i vitros gent= 0. 763 and 0. 739 versus expected 2. 73 ug/ml. Biorad lev 2 vitros gent= 3. 4 versus expected 5. 3 ug/ml. Biorad lev 3 vitros gent = 5. 0 versus expected 7. 9 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. However, no vitros gent patient sample results were questioned. There was no allegation of patient harm as a result of this event. This report is number two of three mdr? S for this event. Three 3500a forms are being submitted for this event as three devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12257362]
The investigation determined that non-reproducible vitros gent results were obtained on three different quality control fluids processed on a vitros 5,1fs chemistry system. The most likely cause for this event is related to vitros gent reagent lot 1512-09-3511, as non-reproducible lower than expected results were obtained using three particular reagent packs from lot 1512-09-3511. There is no indication that the vitros 5,1fs instrument issue contributed to the event. The assignable cause for the event is related to vitros gent reagent lot 1512-09-3511.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2014-00020 |
| MDR Report Key | 4021414 |
| Report Source | 05 |
| Date Received | 2014-08-19 |
| Date of Report | 2014-08-19 |
| Date of Event | 2014-07-22 |
| Date Mfgr Received | 2014-07-22 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-09-04 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS GENT REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LCD |
| Date Received | 2014-08-19 |
| 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 | 2014-08-19 |