MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-08 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[129048801]
The investigation determined that lower than expected vitros digoxin (dgxn) results were obtained from a non-vitros mas quality control (qc) fluid and a vitros therapeutic drug monitoring performance verifier (tdm pv) fluid processed using vitros dgxn slides in combination with a vitros 5600 integrated system. The investigation was unable to determine an assignable cause. The initial unexpected results of 1. 77 on (b)(6) 2018 and 1. 98 on (b)(6) 2018 were both resolved by retesting of the control fluid. After a later calibration event, the issue recurred with multiple calibration events unable to resolve it. This indicates the possibilities of improper fluid handling or the vitros dgxn slide lot contributing to the event. However, a vitros dgxn within-run precision test was within the acceptable guidelines indicating vitros dgxn slide lot 1916-0251-2165 was performing as intended. The issue was later resolved by calibrating with a different set of the same lot of calibrators. The vitros 5600 integrated system was performing as intended and did not likely contribute to the event as within-run precision performance was within acceptable guidelines. In addition, continual tracking and trending of complaints has not identified any signals that show a potential systemic issue with vitros dgxn slide lot 1916-0251-2165.
Patient Sequence No: 1, Text Type: N, H10
[129048802]
A customer reported lower than expected quality control (qc) results from both a non-vitros mas qc fluid and a vitros therapeutic drug monitoring performance verifier (tdm pv) obtained using vitros digoxin (dgxn) slides on a vitros 5600 integrated system. Mas lot chu1907a l3 results of 1. 77, 1. 98 and 1. 80 ng/ml vs. The expected result of 2. 60 ng/ml. Tdm pv iii r5360 result of 1. 62 ng/ml vs. The expected result of 2. 12 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The unexpected vitros dgxn results were generated from non-patient fluids and there was no allegation of patient harm as a result of the event. This report is number 3 of 4 mdr? S for this event. Four (4) 3500a forms are being submitted for this event as 4 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 | 1319809-2018-00122 |
| MDR Report Key | 8052021 |
| Date Received | 2018-11-08 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-10-08 |
| Date Mfgr Received | 2018-10-14 |
| Device Manufacturer Date | 2018-08-12 |
| Date Added to Maude | 2018-11-08 |
| 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 DGXN SLIDES |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LFM |
| Date Received | 2018-11-08 |
| Catalog Number | 8343386 |
| Lot Number | 1916-0251-2165 |
| Device Expiration Date | 2019-01-01 |
| 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 | 2018-11-08 |