MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for VITROS CHEMISTRY PRODUCTS K+ SLIDES 8157596 manufactured by Ortho-clinical Diagnostics.
[89522342]
The investigation determined that multiple higher than expected vitros na+ and vitros k+ results were obtained from two vitros performance verifier qc fluid lots when tested on a vitros 350 chemistry system. The investigation was unable to determine a definitive assignable cause. Based on atypical, lower than expected historical quality control data, a vitros na and vitros k+ reagent lot performance issues cannot be ruled out as contributing to the event. However, although not confirmed by the investigation, since the results in question were higher than expected, user error due to pre-analytical fluid handling cannot be completely ruled out as a contributing factor. The customer? S vitros na+ within-run precision test results were acceptable, indicating the vitros 350 instrument was performing as expected. The customer recalibrated the vitros k+ and vitros na+ with fresh reagents and calibrator fluids, which resolved the customer? S concern.
Patient Sequence No: 1, Text Type: N, H10
[89522343]
A customer observed higher than expected vitros na+ and vitros k+ results when testing two different lots of vitros performance verifiers on a vitros 350 chemistry system. Vitros pv l1 lot t5608 vitros k+ result 4. 04 mmol/l versus expected 2. 92 mmol/l. Vitros pv l1 lot q5358 vitros na+ result 169. 6 mmol/l versus expected 120. 1 mmol/l. Vitros pv l1 lot t5608 vitros na+ result 169. 8 mmol/l versus expected 120. 9 mmol/l. Biased results of the direction and magnitude observed could lead to inappropriate physician action. Ortho was not made aware of any patient sample results being affected. However, the investigation cannot definitively conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report is number one of three emdr? S for this event. Three (3) 3500a forms are being submitted for this event as 3 devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2017-00173 |
| MDR Report Key | 6891654 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-08-31 |
| Date Mfgr Received | 2017-08-31 |
| Device Manufacturer Date | 2016-10-07 |
| Date Added to Maude | 2017-09-25 |
| 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 | 2017-09-25 |
| Catalog Number | 8157596 |
| Lot Number | 4102-0961-5954 |
| ID Number | 10758750010233 |
| Device Expiration Date | 2018-04-01 |
| 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 | 2017-09-25 |