MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-07 for VITROS CHEMISTRY PRODUCTS CKMB SLIDES 8001133 manufactured by Ortho-clinical Diagnostics.
[40121998]
The assignable cause of the event is a known limitation of the vitros ckmb slide assay. The results of the non-vitros fractionation indicate that 34% of the total ck enzyme in the sample consists of the macro type i isoenzyme. Per the vitros ckmb slide assay instruction for use (ifu), macro ck type i and type ii can cause falsely elevated vitros ckmb results. There was no indication the vitros ckmb microslide reagent or the vitros 5600 instrument malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[40121999]
The customer reported higher than expected vitros ckmb results were obtained from a single patient sample using two different lots of vitros ckmb slides on a vitros 5600 analyzer, when compared to a non-vitros fractionation method. Biased results of the direction and magnitude observed may lead to inappropriate physician action. Vitros ckmb slide lot 4935-0202-5258. Patient sample result of 104 u/l vs. The expected result of <16 u/l. Vitros ckmb slide lot 4935-0202-6522. Patient sample result of 104 u/l vs. The expected result of <16 u/l. The higher than expected results were not reported outside of the laboratory. There was no report of patient harm as a result of this event. This report is number 2 of 2 mdr's for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2016-00033 |
| MDR Report Key | 5484451 |
| Date Received | 2016-03-07 |
| Date of Report | 2016-03-07 |
| Date of Event | 2016-01-21 |
| Date Mfgr Received | 2016-02-12 |
| Device Manufacturer Date | 2015-08-31 |
| Date Added to Maude | 2016-03-07 |
| 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 | 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 | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CKMB SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JHX |
| Date Received | 2016-03-07 |
| Catalog Number | 8001133 |
| Lot Number | 4935-0202-6522 |
| Device Expiration Date | 2017-02-01 |
| 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 | 2016-03-07 |