MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-16 for VITROS CHEMISTRY PRODUCTS K+ SLIDES 8157596 manufactured by Ortho-clinical Diagnostics.
[100529116]
The investigation determined that a higher than expected vitros k+ patient result was obtained from the initial test event on a vitros 5600 system, compared to the expected result obtained from retesting the same sample on the same vitros 5600 system. The investigation was unable to determine a definitive assignable cause. Pre-analytical sample processing could not be ruled out as a contributing factor, as the customer is not adhering to the sample collection device manufacturer? S recommendations for sample centrifugation. It is likely that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed. Based on historical quality control data and results of precision testing, there was no evidence to suggest a malfunction of the vitros 5600 integrated systems or the vitros k+ reagent.
Patient Sequence No: 1, Text Type: N, H10
[100529117]
A customer observed a higher than expected vitros k+ result obtained from a single patient sample tested on a vitros 5600 integrated system compared to the expected result obtained from a retest of the same sample. Vitros k+ patient result of 4. 13 mmol/l versus the expected result of 2. 83 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if the event occurred undetected. The vitros k+ 4. 13 mmol/l result was reported from the laboratory; however, a corrected report was issued. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00018 |
| MDR Report Key | 7276692 |
| Date Received | 2018-02-16 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-01-19 |
| Date Mfgr Received | 2018-01-19 |
| Device Manufacturer Date | 2017-07-26 |
| Date Added to Maude | 2018-02-16 |
| 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 | 2018-02-16 |
| Catalog Number | 8157596 |
| Lot Number | 4102-0976-2843 |
| ID Number | 10758750010233 |
| Device Expiration Date | 2019-01-01 |
| 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 | 2018-02-16 |