MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-09 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[90312217]
The investigation determined that a lower than expected vitros dgxn quality control result was obtained on a vitros 5600 integrated system. The most likely assignable cause for the event is instrument related. A vitros dgxn within-run precision test was unacceptable, however, acceptable vitros dgxn performance was obtained after an ortho field engineer replaced the immuno wash fluid (iwf) pump and tubing, and performed all necessary adjustments.
Patient Sequence No: 1, Text Type: N, H10
[90312218]
A customer observed lower than expected vitros dgxn results from a quality control fluid on a vitros 5600 integrated system. Vitros tdm performance verifier(lot l5351) results of 2. 35, 2. 58, 2. 54, and 2. 49 nmol/l vs. The range of means midpoint value of 3. 27 nmol/l. No patient samples were in question for vitros dgxn over the time frame of the event. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00090 |
| MDR Report Key | 6928093 |
| Date Received | 2017-10-09 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2017-09-11 |
| Device Manufacturer Date | 2013-04-27 |
| Date Added to Maude | 2017-10-09 |
| 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 | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | KXT |
| Date Received | 2017-10-09 |
| 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 | 2017-10-09 |