MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-21 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[3198330]
The customer obtained a non-reproducible, higher than expected vitros ckmb result (patient 1= 6. 29 vs. An expected result= 1. 46 ng/ml) from a single patient sample run on the vitros 5600 integrated system. The higher than expected result was reported out of the laboratory. Biased results of the magnitude and direction observed may lead to inappropriate physician action. However, the affected sample was repeated for an undetermined reason. A corrected report was issued. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10632862]
The investigation determined that a non-reproducible, higher than expected vitros ckmb result was obtained from a single patient sample run on the vitros 5600 integrated system. An ocd field engineer performed service actions to multiple subsystems of the analyzer to return the instrument to expected performance. Additionally, the sample in question was not processed in accordance with the tube manufacturer? S recommendations. It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed. The most likely cause is analyzer related. Additionally, pre-analytical sample processing could not be ruled out as a contributing factor. There was no evidence to suggest a reagent related issue contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2013-00065 |
| MDR Report Key | 3014781 |
| Report Source | 05 |
| Date Received | 2013-03-21 |
| Date of Report | 2013-03-21 |
| Date of Event | 2013-02-03 |
| Date Mfgr Received | 2013-02-20 |
| Device Manufacturer Date | 2011-01-20 |
| Date Added to Maude | 2013-05-22 |
| 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 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JLB |
| Date Received | 2013-03-21 |
| Catalog Number | 6802413 |
| 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 | 2013-03-21 |