MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT 1896836 manufactured by Ortho-clinical Diagnostics.
[50919704]
The investigation determined that non-reproducible, higher than expected vitros ckmb results were obtained from a quality control fluid processed on the vitros eci immunodiagnostic system. The investigation could not determine a definitive assignable cause with the information provided. Results from precision testing of the customer? S vitros eci immunodiagnostic system prior to and following service actions by an ortho field engineer indicate that the instrument was operating as expected. There was no indication that an instrument performance issue contributed to the event. Historical qc data shows no evidence of a reagent performance issue, however, since quality control fluid was affected, an unexpected reagent related issue cannot be entirely ruled out as contributing to the event. Finally, inappropriate pre-analytical sample handling could not be entirely ruled out as contributing to the higher than expected ckmb results as sufficient information was not provided to determine whether the customer was following an appropriate fluid handling protocol. A definitive assignable cause for the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[50919706]
The customer obtained non-reproducible, higher than expected vitros ckmb results from quality control fluid tested on a vitros eci immunodiagnostic system. Level 1 qc: 8. 45, 6. 95, 7. 12, 5. 69, 6. 96, 6. 48 and 6. 52 ng/ml versus expected result of 3. 27 ng/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The non-reproducible, higher than expected vitros ckmb quality control fluid results were not reported outside of the laboratory. No evidence was provided by the customer to suggest that patient results were affected, however the investigation cannot conclude that patient results would not to be affected if the event were to recur undetected. There is no allegation of actual patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2016-00126 |
| MDR Report Key | 5811269 |
| Date Received | 2016-07-21 |
| Date of Report | 2016-07-21 |
| Date of Event | 2016-06-19 |
| Date Mfgr Received | 2016-06-27 |
| Device Manufacturer Date | 2015-11-18 |
| Date Added to Maude | 2016-07-21 |
| 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 | 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 | FELINDRE MEADOWS PENCOED |
| Manufacturer City | BRIDGEND, WALES CF355PZ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF35 5PZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JHX |
| Date Received | 2016-07-21 |
| Catalog Number | 1896836 |
| Lot Number | 1900 |
| Device Expiration Date | 2016-08-12 |
| 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 | 2016-07-21 |