MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-04 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[4145974]
A customer observed non-reproducible lower than expected vitros gent quality control results on a vitros 5,1 fs chemistry system. Vitros gent results of 2. 37, 3. 91, and 3. 81? G/ml were obtained from the biorad level 2 control fluid versus the expected value of 5. 67? G/ml, and vitros gent results of 6. 34 and 6. 44? G/ml were obtained from the biorad level 3 control fluid versus the expected value of 9. 50? G/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. There was no report of patient harm as a result of this event. This report is number one 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. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11400939]
The investigation determined that non-reproducible lower than expected vitros gent quality control results were obtained on a vitros 5,1 fs chemistry system. Results of precision testing suggested that the vitros 5,1 fs chemistry system was operating as expected at the time of the event. An ocd field engineer proactively made subsystem adjustments and performed the water blank test, however, the investigation cannot conclude that these service actions were directly related to the root cause of the event. After completion of the service actions, the customer stated that acceptable vitros gent performance was observed. The investigation was unable to determine a definitive root cause. However, the vitros gent reagent packs in use could not be ruled out as a potential contributing factor. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2013-00053 |
| MDR Report Key | 3499639 |
| Report Source | 05 |
| Date Received | 2013-12-04 |
| Date of Report | 2013-12-04 |
| Date of Event | 2013-11-02 |
| Date Mfgr Received | 2013-11-05 |
| Device Manufacturer Date | 2013-02-13 |
| Date Added to Maude | 2014-03-14 |
| 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. JOSEPH FALVO |
| 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 | 2013-12-04 |
| Catalog Number | 6801711 |
| Lot Number | 1512-08-2760 |
| Device Expiration Date | 2014-11-01 |
| 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 | 2013-12-04 |