MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-04 for VITROS CHEMISTRY PRODUCTS THEO SLIDES 1307164 manufactured by Ortho-clinical Diagnostics.
[39988114]
The investigation determined that lower than expected theophylline results were obtained from a non-vitros linearity fluid using vitros theo reagent with a vitros 5600 integrated system. A definitive assignable cause could not be determined. Vitros theo precision testing was not performed to verify instrument performance at the time of the events, therefore unexpected instrument performance cannot be ruled out as contributing to the event. The recommended handling protocols and stability characteristics of the non-vitros linearity fluids are not known, therefore inappropriate pre-analytical sample handling cannot be ruled out as a contributing factor. A review of historical quality control data showed atypical within-lab precision leading up to the events and on the day of the events, one level of quality control was outside of the customer? S established range. This indicates that the vitros theo reagent lot 2448-0088-6607 was not performing as expected when the lower than expected results were obtained. The lower than expected results were obtained after the customer performed a x5 dilution of the non-vitros linearity fluid. However an appropriate vitros theo result was previously obtained using a x2 dilution of the linearity fluid, which correlated with the result obtained from testing of the neat fluid. Good laboratory practice when the initial value is greater than the reportable range of the assay is to use values obtained using a minimal dilution factor. It is not known why the customer further diluted the non-vitros linearity fluid, or why this value was reported.
Patient Sequence No: 1, Text Type: N, H10
[39988115]
A customer obtained lower than expected theophylline results (34. 1 ug/ml and 33. 9 ug/ml vs. Expected result of 48. 05 ug/ml) from a non-vitros linearity fluid, using vitros theo reagent with a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected theophylline results were generated from non-patient fluids and there is no allegation of patient harm as a result of the event. This report is number two of two mdrs for this event. Two 3500a forms are being submitted for this event as two devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2016-00031 |
| MDR Report Key | 5479632 |
| Date Received | 2016-03-04 |
| Date of Report | 2016-03-04 |
| Date of Event | 2015-11-20 |
| Date Mfgr Received | 2016-02-08 |
| Device Manufacturer Date | 2015-09-02 |
| Date Added to Maude | 2016-03-04 |
| 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 THEO SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | KLS |
| Date Received | 2016-03-04 |
| Catalog Number | 1307164 |
| Lot Number | 2448-0088-6607 |
| Device Expiration Date | 2017-03-01 |
| 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 | 2016-03-04 |