MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-12-11 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[130658669]
The investigation concluded that lower than expected vitros chemistry products dgxn results were attained from non-vitros quality control (qc) fluids using vitros dgxn slides in combination with a vitros 5,1 fs chemistry system. An assignable cause for the event could not be determined. After the customer performed a secondary calibration event using vitros dgxn lot 1916-0251-2567 on (b)(6) 2018, the qc results were acceptable. Although it is unknown if the customer performed maintenance activities, the precision after this calibration event improved suggesting possible action by the customer prior to the calibration event may have mitigated a possible unknown analyzer related issue. Therefore, an analyzer related issue cannot be ruled out nor confirmed as the cause of the event. Because the calibration parameters for both the original calibration event and (b)(6) 2018 calibration event were similar, a suboptimal calibration is not a likely cause of the lower than expected results. Furthermore, the improved performance using the same reagent indicates the vitros dgxn reagent lot 1916-0251-2567 did not contribute to the event. The continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros chemistry products dgxn slides lot 1916-0251-2567.
Patient Sequence No: 1, Text Type: N, H10
[130658670]
A customer reported lower than expected vitros digoxin (dgxn) results from non-vitros quality control (qc) fluids processed using vitros chemistry products dgxn slides in combination with a vitros 5,1 fs chemistry system. Non-vitros qc fluid biorad level 2 vitros dgxn results of 1. 97, 1. 92, 1. 90, 1. 90, 1. 91, 1. 75, 1. 94, 1. 99, 1. 60, 1. 64, 1. 93, 1. 75, 1. 84 and 1. 67 mg/dl versus the expected vitros dgxn result of 3. 22 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The lower than expected vitros dgxn results were obtained when processing quality control fluids. However, it cannot be concluded that patient sample results were not affected or would not be affected if the event were to recur undetected. There were no allegations of patient harm as a result of this event. This report is number 6 of 14 mdr? S for this event. Fourteen (14) 3500a forms are being submitted for this event as 14 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 | 1319809-2018-00156 |
| MDR Report Key | 8150309 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-12-11 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-11-19 |
| Device Manufacturer Date | 2018-08-25 |
| Date Added to Maude | 2018-12-11 |
| 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 | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS DGXN SLIDES |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LFM |
| Date Received | 2018-12-11 |
| Catalog Number | 8343386 |
| Lot Number | 1916-0251-2567 |
| Device Expiration Date | 2019-01-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-12-11 |