MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-23 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[83748288]
The investigation determined the customer obtained higher than expected vitros k+ and vitros na+ results from a non-vitros quality control fluid and a higher than expected vitros k+ result from a single patient sample processed using vitros chemistry products k+ slides lot 4102-0973-1147 and vitros chemistry products na+ slides lot 4208-0969-1081 on a vitros 5600 integrated system (s/n (b)(4)). The unacceptable patient sample and qc results were obtained after recalibration of vitros na+ and vitros k+ using vitros chemistry products calibrator kit 2, lot 0257. The investigation concludes that user error with preparation of the calibrator fluid is the assignable cause. The instructions for use (ifu) for the vitros chemistry products calibrator kit 2 instructs the customer to add 3. 0 ml of the appropriate diluent to each vial. However, the customer prepared the calibration fluid using a 5ml pipette. Suboptimal calibrations were obtained for vitros na+ and vitros k+ which subsequently generated the unacceptable qc and patient sample results. Recalibration of vitros na+ and vitros k+ using calibrators prepared with a 3ml pipette has resolved the issue as the post calibration qc results were acceptable. There was no indication that the vitros 5600 integrated system, or the vitros slide lots in use malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[83748289]
A customer observed higher than expected vitros potassium (k+) and vitros sodium (na+) results obtained from a non-vitros quality control (qc) fluid, and a higher than expected vitros k+ result for a single patient sample, using vitros chemistry products k+ slides and vitros chemistry products na+ slides processed using a vitros 5600 integrated chemistry system. Level 1 omnicore control lot 19021a vitros na+ result 206. 6, 210. 1, 208. 3, 208. 6, 194. 2 mmol/l versus expected customer baseline na+ result 119. 8 mmol/l. Level 1 omnicore control lot 19021a vitros k+ result 4. 55, 4. 59, 4. 56, 4. 56, 4. 29 mmol/l versus expected customer baseline k+ result 2. 64 mmol/l. Patient sample result 5. 1 mmol/l versus expected result 2. 9 mmol/l from alternative vitros 5600 system. Biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected. The patient result was not reported from the laboratory and there was no allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00014 |
| MDR Report Key | 6812645 |
| Date Received | 2017-08-23 |
| Date of Report | 2017-08-23 |
| Date of Event | 2017-08-02 |
| Date Mfgr Received | 2017-08-02 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2017-08-23 |
| 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 | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JIX |
| Date Received | 2017-08-23 |
| Catalog Number | 1662659 |
| Lot Number | 0257 |
| ID Number | 10758750009503 |
| Device Expiration Date | 2018-12-19 |
| 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 | 2017-08-23 |