MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-12 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[100263455]
The investigation determined that lower than expected vitros dgxn results were obtained for performance verifier fluid results processed using vitros digoxin (dgxn) slides lot 1913-0247-5668 on a vitros 4600 chemistry system (s/n (b)(4)). The investigation was unable to determine an assignable cause. There is no indication that the instrument is the cause of the lower than expected results as quality control results were acceptable. A reagent issue cannot be ruled out as a contributing factor as elevated imprecision was observed across the measuring range and for multiple fluid types. However, all testing has shown performance of vitros dgxn slide lot 1913-0247-5668 is within claims, labeling and specifications.
Patient Sequence No: 1, Text Type: N, H10
[100263456]
An ortho clinical diagnostics scientist reported lower than expected performance verifier fluid results processed using vitros digoxin (dgxn) slides on a vitros 4600 chemistry system. Performance verifier level 2 (lot m5007) results of 1. 492, 1. 466, 1. 671 nmol/l vs. An expected result of 2. 246 nmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. No results were reported outside of the laboratory. There was no report of patient harm. (b)(4). 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00015 |
| MDR Report Key | 7262940 |
| Date Received | 2018-02-12 |
| Date of Report | 2018-02-12 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2018-01-15 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2018-02-12 |
| 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 DGXN SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LFM |
| Date Received | 2018-02-12 |
| Catalog Number | 8343386 |
| Lot Number | 1913-0247-5668 |
| ID Number | 10758750004782 |
| Device Expiration Date | 2018-04-15 |
| 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 | 2018-02-12 |