MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-06 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[90209789]
The investigation determined that higher and lower than expected vitros na+ quality control results were obtained when processing non-vitros biorad lot 31830 controls and vitros performance verifier control lot l5005 on two vitros 5600 integrated systems. The investigation determined the assignable cause to be user error due to a combination of not calibrating na+ slides for an electrolyte reference fluid (erf) lot change and improper calibrator kit fluid preparation. The lower than expected biorad level 2 na+ result was obtained using a new vitros erf lot which was not the erf lot used during the initial na+ calibration event. In the? When to calibrate? Section of the vitros na+ instructions for use (ifu) the customer is instructed to calibrate na+ whenever the vitros electrolyte reference fluid lot number changes. In response to the low biorad quality control results, the customer recalibrated vitros na+ multiple times using 2 different calibrator kit lots (lots 257 and 226) and obtained higher than expected quality control results on biorad and vitros performance verifier controls. It was concluded that the calibrator fluids were not prepared correctly which subsequently caused a suboptimal na+ calibration and the higher than expected biorad qc results. Acceptable vitros na+ quality control results were obtained after a recalibration event was performed using properly handled calibrator fluids and the new erf lot. The investigation found no indication the vitros 5600 chemistry system or vitros na+ slide lot contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[90209790]
The investigation determined that higher and lower than expected vitros na+ quality control results were obtained when processing non-vitros biorad controls and vitros performance verifier controls on two vitros 5600 integrated systems. Vitros 5600 integrated system (s/n (b)(4)): (b)(6). Vitros 5600 integrated system (s/n (b)(4)): biorad lot 31831 level 1 = 139. 34 and 141. 66 mmol/l versus expected 124. 3 mmol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. It is unknown if patient results were reported during the time frame of the event. Ortho was not made aware of any misreported results and there was no allegation of patient harm as a result of this event. This report is number 1 of 3 mdr? S for this event. Three (3) 3500a forms are being submitted for this event as 3 devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00018 |
| MDR Report Key | 6921622 |
| Date Received | 2017-10-06 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-09-08 |
| Date Mfgr Received | 2017-09-08 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2017-10-06 |
| 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 DIAGNOSTICS |
| Product Code | JIX |
| Date Received | 2017-10-06 |
| Catalog Number | 1662659 |
| Lot Number | 257 |
| 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 | 2017-10-06 |