MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[96961506]
The investigation determined that lower than expected vitros dgxn quality control results were obtained on a vitros 5600 integrated system. The assignable cause for the event is unknown. An unknown issue related to the vitros dgxn slide lot 1913-0246-3367 cannot be ruled out. Currently, ortho has an investigation of vitros dgxn across multiple lots of coating 0246 and related to imprecision, qcl, qch and accuracy high/low (qerts complaint investigation (b)(4)). The investigation could not rule out that this event was not related to this issue. When the vitros quality control results shifted low, the calibration in use was performed on (b)(6) 2017. Therefore, a calibration driven event was not likely the cause of the issue. Recalibration of the same slide lot did not resolve the issue. The customer put an alternate vitros dgxn slide into use, as the inventory of vitros dgxn slide lot 1913-0246-3367 was depleted. However, acceptable vitros dgxn performance was not obtained until the customer performed a second calibration of the alternate dgxn slide lot. No information was provided concerning the fluid handling protocol in use at the site. It is unknown if improper fluid handling protocol contributed to the events. A vitros crbm within-run precision test, used to assess the performance of the vitros 5600 system was acceptable, however, the precision test occurred 15 days after the initial event. Therefore, the performance of the vitros 5600 system at the time of the event is unknown and an unknown instrument related issue cannot be ruled out as contributing to the event.
Patient Sequence No: 1, Text Type: N, H10
[96961507]
A customer observed lower than expected vitros dgxn results from a single level of non-vitros biorad control fluid using vitros dgxn slide lot 1913-0246-3367 tested on a vitros 5600 integrated system. Biorad lot 47950 results of 1. 91, 1. 96, and 1. 82 ng/ml vs. The baseline mean result of 2. 79 ng/ml the customer made no allegation that patient sample results were affected, however, the investigation cannot conclude that patient sample results were not, or would not be affected if the event were to recur undetected. There was no allegation of patient harm. This report is number one of three mdr? S for this event. Three 3500a forms are being submitted for this event as three 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 | 1319809-2018-00001 |
| MDR Report Key | 7178238 |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-09 |
| Date of Event | 2017-12-04 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2017-08-17 |
| Date Added to Maude | 2018-01-10 |
| 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 | 2018-01-10 |
| Catalog Number | 8343386 |
| Lot Number | 1913-0246-3367 |
| ID Number | 10758750004782 |
| Device Expiration Date | 2018-01-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-01-10 |