MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[80631625]
The investigation determined that a lower than expected vitros dgxn result was obtained when testing a proficiency sample using a vitros 4600 chemistry system. The investigation was unable to determine the assignable cause of the event. A review of historical quality control data concluded that there is no issue with the vitros dgxn slide lot based on the dgxn qc performance. The alt and dgxn within-run marker precision results were acceptable indicating the vitros 4600 chemistry system was performing as intended. However, an ortho fe has been requested on site due to condition code u90-382 (ir wash error) that occurred one time during the dgxn precision testing. Therefore, an instrument issue cannot be entirely ruled out as a contributing factor to this event. The (b)(6) samples are from the 2017 c a survey, were initially processed (b)(6) 2017 and stored frozen. The recommended open storage is 2-8 c for 7 days. Long term storage and stability for these cap fluids is unknown, therefore, improper fluid handling (storage) cannot be ruled out as contributing to the event.
Patient Sequence No: 1, Text Type: N, H10
[80631626]
The customer observed a lower than expected vitros dgxn result when testing a (b)(6) proficiency sample on a vitros 4600 chemistry system. Cap sample dgxn result 1. 7 ng/ml versus expected dgxn result 2. 81 ng/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The vitros dgxn result was obtained when testing a proficiency sample. There was no allegation of patient harm as a result of the event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2017-00132 |
| MDR Report Key | 6718604 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-07-17 |
| Date of Event | 2017-06-19 |
| Date Mfgr Received | 2017-06-19 |
| Device Manufacturer Date | 2017-04-05 |
| Date Added to Maude | 2017-07-17 |
| 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 | 2017-07-17 |
| Catalog Number | 8343386 |
| Lot Number | 1913-0242-0036 |
| ID Number | 10758750004782 |
| Device Expiration Date | 2017-09-01 |
| 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 | 2017-07-17 |