MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for VITROS CHEMISTRY PRODUCTS CRP SLIDES 8097990 manufactured by .
[112851778]
The investigation has determined that a lower than expected vitros crp result was obtained when processing a patient sample (undiluted) on a vitros 5600 integrated system when compared to the vitros crp result obtained from the same patient sample tested using a 5x dilution. The investigation was unable to determine the assignable cause for this event. Within-run precision testing that would assess both the performance of the vitros 5600 system and the vitros crp slides was not performed upon request. Therefore, an instrument related issue could not be ruled out as contributing to the event. Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product crp lot 3740-0967-5332.
Patient Sequence No: 1, Text Type: N, H10
[112851779]
A customer obtained a lower than expected vitros crp result from an undiluted patient sample on a vitros 5600 integrated system when compared to the vitros crp result obtained from the same patient sample tested using a 5x dilution. Patient sample (undiluted) vitros crp result <5. 0 mg/l vs. The diluted vitros crp result 27. 0 mg/l. Biased results of the direction and magnitude observed may lead to inappropriate medical action if not detected. The lower than expected vitros crp result of <5. 0 mg/l was reported outside of the laboratory; however, the result was questioned by the physician. A corrected report was issued and there was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2018-00091 |
| MDR Report Key | 7638853 |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2017-11-08 |
| Date Added to Maude | 2018-06-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 CRP SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | DCK |
| Date Received | 2018-06-26 |
| Catalog Number | 8097990 |
| Lot Number | 3740-0967-5332 |
| ID Number | 10758750004355 |
| Device Expiration Date | 2018-08-01 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CRP SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | DCK |
| Date Received | 2018-06-26 |
| Catalog Number | 8097990 |
| Lot Number | 3740-0967-5332 |
| ID Number | 10758750004355 |
| Device Expiration Date | 2018-08-01 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2018-06-26 |