MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-04 for VITROS CHEMISTRY PRODUCTS K+ SLIDES 8157596 manufactured by Ortho-clinical Diagnostics.
[104820853]
The investigation determined the customer obtained higher than expected vitros na+ and vitros k+ results from a single patient sample processed using vitros chemistry products na+ slides lot 4211-0971-2325 and vitros chemistry k+ slides lot 4102-0978-3231 on a vitros 5,1 fs chemistry system (s/n (b)(4)). The assignable cause of the event could not be determined. Multiple products were affected and therefore a reagent performance issue is unlikely. As the issue started when the electrolyte reference fluid (erf) reservoir was changed, an unknown protocol issue with erf fluid handling that affected both the vitros na+ and k+ assays cannot be ruled out as contributing to the event. In addition, an instrument related issue cannot be ruled out as contributing to the event. Multiple service actions were performed to the vitros 5,1 erf module, including cleaning and replacing the erf tubing and tip carrier. Since the last service event, qc and performance verifier results have been acceptable, however, as pre-service within-run precision testing was not performed, it is unknown if the service actions alone resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
[104820854]
A customer observed higher than expected sodium (na+) and potassium (k+) results obtained from a single patient sample using vitros chemistry products na+ slides and vitros chemistry products k+ slides processed using a vitros 5,1 chemistry system. Vitros na+ results of 147. 4 and 154. 1 mmol/l vs. The expected result of 128. 4 mmol/l. Vitros k+ result of 3. 52 mmol/l vs. The expected result of 2. 92 mmol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The higher than expected patient sample results were not reported outside the laboratory and there were no allegations of harm as a result of this event. This report corresponds to ortho clinical diagnostics (ortho) inc. (b)(4). This report is number three of three 3500a forms filed for this event, as three devices were involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00063 |
| MDR Report Key | 7395300 |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-12-22 |
| Date Mfgr Received | 2018-03-09 |
| Device Manufacturer Date | 2017-08-11 |
| Date Added to Maude | 2018-04-04 |
| 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 |
| 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 | 2018-04-04 |
| Catalog Number | 8157596 |
| Lot Number | 4102-0978-3231 |
| ID Number | 10758750010233 |
| Device Expiration Date | 2019-02-01 |
| 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 | 2018-04-04 |