MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-12 for VITROS CHEMISTRY PRODUCTS NA+ SLIDES 8379034 manufactured by Ortho-clinical Diagnostics.
[65110198]
The investigation determined that lower than expected, non-reproducible vitros na+, crea, and k+ results were obtained from 3 different patients when tested on a vitros 5600 integrated system. The investigation was unable to determine a definitive assignable cause. However, based on reproducible results obtained from retesting, the customer concluded that the vitros results initially obtained from each sample were likely due to a pre-analytical sample related issue. The protocol used for pre analytical sample collection and processing at the alternate site is unknown, and therefore cannot be ruled out as a potential contributing factor. Although there were no indications of an instrument malfunction, a within-run precision marker test was not completed, and therefore, an instrument issue cannot be completely ruled out as a contributing factor to the event. Since no quality control data was provided, the performance of the affected assays is unknown and cannot be ruled out as contributing to the event. However, as the results for the patient samples were reproducible upon retesting the same samples, it is unlikely the vitros reagent lots in use contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[65110199]
A customer observed lower than expected, non-reproducible vitros na+, crea, and k+ results obtained from 3 different patients when tested on a vitros 5600 integrated system. (b)(6). Biased results of the magnitude and direction observed may lead to inappropriate physician action. The affected results were not reported to the physician, and there was no allegation of patient harm as a result of this event. This report is number 1 of 3 mdr? S for this event. Three (3) 3500a forms are being submitted for this event as 3 devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2017-00001 |
| MDR Report Key | 6247987 |
| Date Received | 2017-01-12 |
| Date of Report | 2017-01-12 |
| Date of Event | 2017-01-16 |
| Date Mfgr Received | 2016-12-16 |
| Device Manufacturer Date | 2016-09-25 |
| Date Added to Maude | 2017-01-12 |
| 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 NA+ SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | KSG |
| Date Received | 2017-01-12 |
| Catalog Number | 8379034 |
| Lot Number | 4202-0958-5644 |
| Device Expiration Date | 2018-03-01 |
| 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 | 2017-01-12 |