MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-09 for VITROS CHEMISTRY PRODUCTS CKMB SLIDES 8001133 manufactured by Ortho-clinical Diagnostics.
[18544258]
The customer reported that a lower than expected vitros ckmb result was obtained from one proficiency sample when tested on a vitros 5,1fs chemistry system using vitros ckmb microslide reagent. Sample cm-01 vitros ckmb result: 15. 00 u/l vs. Expected 21. 36 u/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. No patient samples were affected; 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. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18936043]
The investigation determined that a lower than expected vitros ckmb result was obtained from one proficiency sample when tested on a vitros 5,1fs chemistry system using vitros ckmb microslide reagent. The definitive assignable cause could not be determined. The investigation found that a potential vitros ckmb reagent issue and/or improper pre-analytical sample handling (sample stored past the sample stability recommendations) cannot be ruled out as contributing factors. The investigation demonstrated that the vitros 5,1chemistry system was operating as expected at the time of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2015-00001 |
| MDR Report Key | 4403804 |
| Report Source | 05 |
| Date Received | 2015-01-09 |
| Date of Report | 2015-01-09 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2014-12-12 |
| Device Manufacturer Date | 2014-10-30 |
| Date Added to Maude | 2015-01-29 |
| 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. 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 | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CKMB SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JHS |
| Date Received | 2015-01-09 |
| Catalog Number | 8001133 |
| Lot Number | 4932-0199-8605 |
| Device Expiration Date | 2016-06-01 |
| 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 | 2015-01-09 |