MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-28 for VITROS CHEMISTRY PRODUCTS K+ SLIDES 8157596 manufactured by Ortho-clinical Diagnostics.
[89499495]
The investigation determined that higher and lower than expected vitros k+ results were obtained from two different quality control fluids (vitros performance verifier lot n5113 and non vitros biorad quality control fluid lot 31812) when run on a vitros 350 chemistry system. The most likely assignable cause was related to sub-optimal calibration events. It is possible the customer did not follow proper protocol when changing to a new lot of erf and the lower than expected results may be attributed to the user error. There is no indication of a reagent issue. The same k+ slide lot (lot 4102-0976-2241) was performing as expected on another vitros instrument in the customer's laboratory suggesting the issue was isolated to a single instrument. An instrument issue cannot be completely ruled out as a contributing factor. A within run k+ precision test was not completed successfully.
Patient Sequence No: 1, Text Type: N, H10
[89499496]
A customer observed higher and lower than expected potassium (k+) results from two different quality control fluids when run on a vitros 350 chemistry system. Vitros k+ results for vitros performance verifier (lot n5113) 5. 2, 5. 1, 5. 2, 5. 1, 5. 2, 5. 2, 5. 1, 5. 2, 5. 2, 5. 2, 5. 1, 5. 1, 5. 2, 5. 1, 5. 2, 5. 2, 5. 2, 5. 2 and 5. 1 mmol/l versus the center of the range of means of 2. 84 mmol/l. Vitros k+ result for non-vitros biorad quality control fluid (lot 31812) 4. 90 mmol/l versus the customer? S baseline mean of 6. 36 mmol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected. The higher and lower than expected k+ results were obtained when testing quality control fluids. The customer made no allegations that patient samples were affected and there were no reported allegations of actual patient harm as a result of this event. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. This report corresponds to ortho clinical diagnostics (ortho) inc. Complaint numbers 1938075 / qerts record id 414637.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2017-00176 |
| MDR Report Key | 6900629 |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-09-03 |
| Date Mfgr Received | 2017-09-03 |
| Device Manufacturer Date | 2017-06-29 |
| Date Added to Maude | 2017-09-28 |
| 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 K+ SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | CEM |
| Date Received | 2017-09-28 |
| Catalog Number | 8157596 |
| Lot Number | 4102-0976-2241 |
| ID Number | 10758750010233 |
| Device Expiration Date | 2018-12-01 |
| 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 | 2017-09-28 |