MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-29 for VITROS CHEMISTRY PRODUCTS K+ SLIDES 8157596 manufactured by Ortho-clinical Diagnostics.
[104155960]
The investigation determined that higher than expected vitros na+ and k+ results were obtained from a single vitros pv i lot w5903 quality control fluid, using vitros na+ slide lot 4214-0973-3769 and vitros k+ slide lot 4102-0982-4731 on a vitros 250 chemistry system. The most likely cause of the event is unknown, however, the customer admitted to using inconsistent erf handling protocol, where the erf was not always warmed to analyzer temperature for a minimum of 30 minutes. Therefore, inconsistent erf handling protocol cannot be ruled out as contributing to the event. In addition, the customer did not indicate how long since the vials were reconstituted or how they were stored, therefore, improper fluid handling protocol cannot be ruled out as contributing to the event. Finally, vitros na+ and k+ within-run precision testing was not performed to assess the performance of the vitros 250 system. Therefore, an instrument related issue cannot be completely ruled out as contributing to the event.
Patient Sequence No: 1, Text Type: N, H10
[104155961]
Higher than expected vitros na+ and k+ results were obtained from a single vitros pv i lot w5903 quality control fluid, using vitros na+ slide lot 4214-0973-3769 and vitros k+ slide lot 4102-0982-4731 on a vitros 250 chemistry system. The following results breached vitros na+ potential health and safety criteria: vitros pv i lot w5903 na+ results of 157. 0 mmol/l vs. The expected result of 124. 2 mmol/l vitros pv i lot w5903 k+ results of 3. 59 mmol/l vs. The expected result of 2. 96 mmol/l biased results of the direction and magnitude observed could lead to inappropriate physician action if the event were to occur with patient samples. Patient samples were not affected and there were no allegations of harm as a result of this event. However, the investigation cannot conclude that patient sample results would not be affected at the same magnitude if the event were to recur undetected. There were no allegations of patient harm as a result of this event. This report is number two of two mdr? S for this event. Two 3500a forms are being submitted for this event as two devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00057 |
| MDR Report Key | 7382621 |
| Date Received | 2018-03-29 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-03-01 |
| Device Manufacturer Date | 2017-10-20 |
| Date Added to Maude | 2018-03-29 |
| 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 K+ SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | CEM |
| Date Received | 2018-03-29 |
| Catalog Number | 8157596 |
| Lot Number | 4102-0982-4731 |
| ID Number | 10758750010233 |
| Device Expiration Date | 2019-04-01 |
| 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 | 2018-03-29 |