MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-23 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[49157647]
The investigation determined that a non-reproducible, lower than expected amon result was obtained from a quality control fluid when using a vitros 5600 integrated system. The most likely assignable cause is an instrument issue related to incubator contamination. Following maintenance actions by an ortho field engineer, vitros amon within-lab precision and within-run precision were significantly improved.
Patient Sequence No: 1, Text Type: N, H10
[49157648]
A customer reported a non-reproducible, lower than expected amon result obtained on a quality control fluid processed using a vitros 5600 integrated system. Amon result = 150. 0 umol/l vs. Expected 199. 2 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action, should they occur undetected on patient samples. The customer made no allegation that amon patient results were affected. There was no allegation of patient harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2016-00156 |
| MDR Report Key | 5745194 |
| Date Received | 2016-06-23 |
| Date of Report | 2016-06-23 |
| Date of Event | 2016-05-23 |
| Date Mfgr Received | 2016-05-26 |
| Device Manufacturer Date | 2010-06-25 |
| Date Added to Maude | 2016-06-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14626 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JIF |
| Date Received | 2016-06-23 |
| Catalog Number | 6802413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| 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 | 2016-06-23 |