MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-04 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[130044557]
The investigation concluded that lower than expected vitros digoxin (dgxn) results were obtained from a vitros performance verifier (pv) and a non-vitros (biorad) quality control (qc) fluid using vitros dgxn slide lot 1916-0251-2534 in combination with a vitros 250 chemistry system. The investigation determined the most likely assignable cause was user error, related to use of an expired on-analyzer reagent. Additionally, a calibration issue or a reagent issue could not be ruled out as contributing factors, as qc results do not meet expectations. Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros dgxn slide lot 1916-0251-2534. Within run precision testing meets expectations; therefore, the instrument can be ruled out as a contributing factor.
Patient Sequence No: 1, Text Type: N, H10
[130044558]
A customer obtained lower than expected vitros digoxin (dgxn) results from a vitros performance verifier (pv) and a non-vitros (biorad) quality control (qc) fluid using vitros dgxn slide lot 1916-0251-2534, tested on a vitros 250 chemistry system. The results exceeded vitros dgxn potential health and safety criteria when compared to the center of the range of means for the pv and the center of the customer? S range for the non-vitros qc fluid. The results are provided below: vitros performance verifier ii (lot a6018) dgxn result of 1. 4 ng/ml vs. An expected result of 2. 15 ng/ml. Non-vitros biorad quality control fluid (lot 26422) dgxn results of 1. 38, 1. 95, 1. 87, 1. 89, 1. 95, 1. 93, and 1. 91 ng/ml vs. An expected result of 2. 98 ng/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The lower than expected vitros dgxn results were generated from non-patient fluids; however, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. Ortho has not been made aware of any allegation of actual patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00146 |
| MDR Report Key | 8131015 |
| Date Received | 2018-12-04 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-10-26 |
| Date Mfgr Received | 2018-11-07 |
| Device Manufacturer Date | 2018-08-24 |
| Date Added to Maude | 2018-12-04 |
| 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 DIAGNOSTIC |
| Product Code | LFM |
| Date Received | 2018-12-04 |
| Catalog Number | 8343386 |
| Lot Number | 1916-0251-2534 |
| Device Expiration Date | 2019-07-15 |
| 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 | 2018-12-04 |