MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[92054617]
The investigation determined that lower than expected vitros dgxn results were obtained from a single level of vitros vitros performance verifier (pv) fluid using vitros dgxn slide lot 1913-0246-3005, tested on a vitros 5600 integrated system s/n (b)(4). The investigation was unable to determine an assignable cause of the lower than expected vitros dgxn results. Neither a vitros dgxn nor a vitros 5600 system issue cannot be ruled out as a review of condition codes posted by the system could indicate either a system or reagent issue. Following service by an ortho field engineer, which included adjustments to the immuno wash fluid assembly, successful calibration and acceptable quality control results were obtained with an alternative reagent lot.
Patient Sequence No: 1, Text Type: N, H10
[92054618]
A customer obtained lower than expected vitros digoxin (dgxn) results from a vitros performance verifier (pv) fluid. The result was generated using vitros chemistry products dgxn slides processed on a vitros 5600 integrated system. Vitros tdm pv iii lot l53841, vitros dgxn result 1. 86, 1. 93, 1. 95 and 1. 97 ng/ml versus dgxn expected result 2. 56 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. The customer made no allegations that patient sample results were affected. There was no report of patient harm as a result of this event. (b)(4). 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2017-00181 |
| MDR Report Key | 6992782 |
| Date Received | 2017-11-01 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-10-03 |
| Date Mfgr Received | 2017-10-03 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2017-11-01 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 2017-11-01 |
| Catalog Number | 8343386 |
| Lot Number | 1913-0246-3005 |
| ID Number | 10758750004782 |
| Device Expiration Date | 2018-01-01 |
| 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 | 2017-11-01 |