MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-18 for VITROS CHEMISTRY PRODUCTS K+ SLIDES 8157596 manufactured by Ortho-clinical Diagnostics.
[112311697]
The investigation determined that discordant vitros k results were obtained from a single patient sample processed on a vitros 4600 chemistry system and a vitros 5600 integrated system. The likely assignable cause for the event is pre-analytical sample handling. The customer indicated that sample quality is an issue with samples obtained from the satellite lab. The patient sample involved in this event was obtained from the satellite site. It is unknown if the patient sample in question was centrifuged according to the tube manufacturer? S recommendations and therefore, it was concluded that pre-analytical sample handling was a likely contributing factor to the event. Based on acceptable historical vitros k+ quality control data, a vitros k+ reagent issue was ruled out as a contributing factor. Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issues with the vitros k+ lot. Acceptable within run na+ and k+ precision tests were processed on both vitros systems indicating an instrument issue was not a contributing factor. There is no evidence to suggest an instrument or assay related issue contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[112311698]
The customer obtained higher than expected vitros potassium (k+) results from a patient sample processed using a vitros 4600 chemistry system and a vitros 5600 integrated system. Vitros k+ results 4. 8, 4. 8, and 4. 7 versus the expected 2. 2 mmol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The unexpected vitros k+ results were not reported outside of the laboratory. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00090 |
| MDR Report Key | 7611896 |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2017-12-07 |
| Date Added to Maude | 2018-06-18 |
| 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 DIAGNOSTICS |
| Product Code | CEM |
| Date Received | 2018-06-18 |
| Catalog Number | 8157596 |
| Lot Number | 4102-0986-6070 |
| ID Number | 10758750010233 |
| Device Expiration Date | 2019-06-01 |
| 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 | 2018-06-18 |