MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for VITROS CHEMISTRY PRODUCTS PHYT SLIDES 8298671 manufactured by Ortho-clinical Diagnostics.
[138221540]
The investigation determined that a lower than expected vitros phenytoin (phyt) result was obtained from a (b)(6) proficiency sample when tested on a vitros 5600 integrated system. The assignable cause of this event is user error due to inappropriate interpretation of an instrument wash error flag generated by the vitros 5600 instrument. The customer did not follow the instructions listed in the actions to perform for the wash error (we) flag and the u90-382 condition code, in order to be able to indicate what the phyt concentration of the cap sample may be. The vitros 5600 integrated system did not generate a phyt result when the proficiency sample was initially run undiluted due to the occurrence of a? We? Flag. The fluid matrix of the proficiency sample most likely contributed to the we flag, and the vitros 5600 instrument was unable to generate a result from that sample. The vitros 5600 instrument operated as intended when the wash error flag was generated, and no phyt result was able to be generated for the sample. The investigation found no evidence to suggest a malfunction of the vitros 5600 integrated system or vitros phyt lot 2617-0168-2514.
Patient Sequence No: 1, Text Type: N, H10
[138221541]
A customer obtained a lower than expected vitros phenytoin (phyt) result from a cap (college of american pathologist) proficiency sample when tested on a vitros 5600 integrated system. Cap sample chm-13, vitros phyt result 3. 0 ug/ml versus the vitros peer mean result 5. 69 ug/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The lower than expected vitros phyt result was obtained when the customer was processing a proficiency sample. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2019-00004 |
| MDR Report Key | 8322692 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-08 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2012-08-24 |
| Date Added to Maude | 2019-02-08 |
| 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 DIAGNOSTIC |
| Product Code | DIP |
| Date Received | 2019-02-08 |
| Catalog Number | 8298671 |
| Lot Number | 2617-0168-2514 |
| Device Expiration Date | 2019-01-15 |
| 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 | 2019-02-08 |