MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-20 for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK 1896836 manufactured by Ortho-clinical Diagnostics.
[36955856]
The investigation determined that a non-reproducible, higher than expected ck-mb result was obtained from a single patient sample using vitros ck-mb reagent with a vitros eci immunodiagnostic system. The definitive assignable cause could not be determined. An instrument issue could not be ruled out as contributing to the event as an assessment of the system has yet to be performed. Historical quality control data was not provided and therefore a vitros ck-mb lot 1850 performance issue could also not be ruled out as a contributing factor. Ortho determined that the customer was not following the sample collection device manufacturer? S recommendations for sample centrifugation, so pre-analytical sample handling could not be ruled out as contributing to the event. It is likely that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[36955857]
A customer obtained a non-reproducible, higher than expected creatine kinase-mb (ck-mb) result from a single patient sample (ck-mb = 3. 32 ng/ml vs. Expected result of 2. 04 ng/ml) using vitros ck-mb reagent with a vitros eci immunodiagnostic system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected ck-mb result was reported from the laboratory, however, there was no allegation of patient harm as a result of the event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2016-00008 |
| MDR Report Key | 5379349 |
| Date Received | 2016-01-20 |
| Date of Report | 2016-01-20 |
| Date of Event | 2015-12-22 |
| Date Mfgr Received | 2015-12-23 |
| Device Manufacturer Date | 2015-07-13 |
| Date Added to Maude | 2016-01-20 |
| 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 |
| 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 | 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 IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JHX |
| Date Received | 2016-01-20 |
| Catalog Number | 1896836 |
| Lot Number | 1850 |
| Device Expiration Date | 2016-05-06 |
| 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 | 2016-01-20 |