MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2017-10-05 for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK 1896836 manufactured by Ortho-clinical Diagnostics.
[89941394]
The investigation has determined that a non-reproducible, lower than expected vitros tropi es result and a vitros ckmb result were obtained from a patient sample using the vitros 5600 integrated system. A definitive root cause could not be determined. Based on acceptable performance of historical tropi es and ckmb quality control data, a reagent issue was ruled out as a potential contributing factor. An instrument related event has been ruled out as a contributing factor as within run precision testing was within the acceptable guidelines. Pre-analytical sample processing could not be ruled out as a contributing factor, as it is unknown if the customer is adhering to the sample collection device manufacturer? S recommendations for sample centrifugation. It is possible 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
[89941395]
A customer obtained non-reproducible, lower than expected troponin i and ckmb results from a patient sample using vitros troponin i es (tropi) reagent and vitros ckmb reagent on a vitros 5600 integrated system. Patient sample results: vitros tropi es result <0. 012 ng/ml versus expected vitros tropi es result 1. 88 ng/ml. Vitros ckmb result 0. 25 ng/ml versus expected vitros ckmb result 19. 6 ng/ml. A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected. The higher than expected results were not reported from the laboratory and there was no allegation patient harm. This report is number two of two mdr's for this event. Two 3500a forms are being submitted for this event as two devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2017-00154 |
| MDR Report Key | 6919005 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2017-10-05 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2017-09-07 |
| Device Manufacturer Date | 2017-05-02 |
| Date Added to Maude | 2017-10-05 |
| 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 | 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 | 3 |
| Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | JHX |
| Date Received | 2017-10-05 |
| Catalog Number | 1896836 |
| Lot Number | 2150 |
| ID Number | 10758750000203 |
| Device Expiration Date | 2018-02-09 |
| 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 | 2017-10-05 |