MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-25 for VITROS 5,1 FS CHEMISTRY SYSTEM 6801375 manufactured by Ortho-clinical Diagnostics.
[4005420]
A customer observed lower than expected vitros k+ results obtained from a single level of quality control fluid (4. 84 and 4. 83 mmol/l) compared to the expected result (6. 10 mmol/l) when tested on a vitros 5,1 fs chemistry system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. No patient samples were run during the time frame of the event. There was no report 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
[11357358]
The investigation determined that lower than expected vitros k+ quality control results were obtained after 3 different k+ reagent calibration events. The root cause of the event was atypical calibration curves. However, no specific cause of the atypical k+ calibration curves was identified. An instrument issue with the vitros 5,1 fs chemistry system is the likely cause of the atypical k+ calibration curves, since following completion of service actions including adjustments to the microslide incubator, the vitros k+ lot in use was recalibrated and acceptable quality control performance was achieved. However, the vitros k+ reagents in use at the time of the events cannot be ruled out as a potential contributing factor. No patient results were reported using the affected vitros k+ reagent lot during 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2013-00198 |
| MDR Report Key | 3487951 |
| Report Source | 05 |
| Date Received | 2013-11-25 |
| Date of Report | 2013-11-25 |
| Date of Event | 2013-10-24 |
| Device Manufacturer Date | 2005-10-03 |
| Date Added to Maude | 2014-03-05 |
| 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 | 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 | 3 |
| Brand Name | VITROS 5,1 FS CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | MZV |
| Date Received | 2013-11-25 |
| Catalog Number | 6801375 |
| 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 | 2013-11-25 |