MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-02 for VITROS CHEMISTRY PRODUCTS PHYT SLIDES 8298671 manufactured by Ortho-clinical Diagnostics.
[146532707]
The investigation concluded that lower than expected vitros chemistry products phenytoin (phyt) results were obtained from a (b)(6) proficiency sample and from vitros tdm pv fluid using vitros phyt slides in combination with a vitros 5600 integrated system. There were two events discovered during the investigation. Event #1: (b)(6) 2018. Vitros phyt slide lot 2617-0167-1476. Proficiency sample chm-13 vitros phyt result of <3. 0 versus expected vitros peer mean of 5. 69 ug/ml. The assignable cause of this event is user error due to an inappropriate interpretation of an analyzer condition code. The vitros 5600 integrated system did not generate a vitros phyt result of < 3. 0 ug/ml for the sample, which was the value reported by the customer. An analyzer condition code occurred when the sample was initially run, and no vitros phyt result was generated at that time. The condition code text states to dilute for a result higher than the measuring range. The customer retested (b)(6) sample chm-13 with a 2x dilution, and generated a result of <6. 0 ug/ml. The customer did not report the vitros phyt result of <6. 0 ug/ml, but reported <3. 0 ug/ml, as they realized the vitros instrument had multiplied a phyt value of <3. 0 ug/ml by the dilution factor of 2. Since the phenytoin concentration of (b)(6) sample chm-13 was not above the vitros phyt measuring range of 3. 0? 40 ug/ml, it was not appropriate to dilute the sample. Event #2: (b)(6) 2018 and (b)(6) 2019. Vitros phyt slide lot 2617-0168-4312. Vitros tdm pv e6508 results of 20. 73 and 14. 84 ug/ml, vs. The baseline mean result of 26. 27 ug/ml. The assignable cause of this event is unknown. The customer stated that during the timeframe of the event, multiple quality control lots were stored in the freezer and refrigerator after opening without regard to open vial stability limits and without separation of lot numbers. It is possible that unsuitable fluids were used or a pre-analytical sample mixup occurred, although this could not be confirmed. A vitros phyt within-run precision test with results within acceptable limits was performed approximately 2 months after the events occurred. This precision test indicated vitros phyt slide lot 2617-0168-4312 was currently performing as intended on the vitros 5600 system. However, it is unknown how the vitros phyt slides were performing on the vitros 5600 system at the time the events occurred. Therefore, an instrument or vitros phyt assay issue cannot be completely ruled out as contributing to the event. Ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros phyt lot 2617-0168-4312. No vitros phyt patient results were questioned. There was no allegation of patient harm as a result of this event. However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected. Ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros phyt lot 2617-0168-4312.
Patient Sequence No: 1, Text Type: N, H10
[146532708]
A complaint was received reporting lower than expected vitros phenytoin (phyt) results from a (b)(6) proficiency sample and vitros therapeutic drug monitoring performance verifiers (tdm pv? S) using vitros chemistry products phenytoin slides on a vitros 5600 integrated system. (b)(6) proficiency sample chm-13 vitros phyt result of <3. 0 ug/ml versus the expected result of 5. 69 ug/ml. Vitros tdm pv e6508 results of 20. 73 and 14. 84 ug/ml, vs. The baseline mean result of 26. 27 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The lower than expected vitros phyt results were obtained when processing (b)(6) and vitros quality control fluids with no patient results being questioned. The investigation could not rule out that patient results would not be affected if the event were to recur undetected. There were no allegations 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. This report corresponds to ortho clinical diagnostics inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2019-00022 |
| MDR Report Key | 8474523 |
| Date Received | 2019-04-02 |
| Date of Report | 2019-04-02 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2018-07-14 |
| Date Added to Maude | 2019-04-02 |
| 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 PHYT SLIDES |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | DIP |
| Date Received | 2019-04-02 |
| Catalog Number | 8298671 |
| Lot Number | 2617-0167-1476 |
| Device Expiration Date | 2018-12-01 |
| 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 | 2019-04-02 |