MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-02 for VITROS CHEMISTRY PRODUCTS AMON SLIDES 1726926 manufactured by Ortho-clinical Diagnostics.
[27679206]
The investigation determined that non-reproducible higher than expected vitros amon quality control results were obtained from two levels of non-vitros control fluids using vitros amon microslides on a vitros 5,1 fs chemistry system. The assignable cause of the event associated with the level 3 qc results is most likely an instrument event related to microslide incubator contamination. The cause of the contamination of the microslide incubator was not identified. A review of historical amon qc performance identified atypical within-laboratory vitros amon qc performance. The assignable cause of the event associated with the level 1 qc result is unknown. The event occured after the instrument had been returned to expected operation and amon reagent was performing as expected. Therefore, an instrument issue and a reagent issue were not likely contributing factors to this event. No details were provided concerning qc fluid handling and storage and therefore, pre-analytical qc fluid handling and storage cannot be ruled out as potential contributing factors to this event.
Patient Sequence No: 1, Text Type: N, H10
[27679207]
The customer observed non-reproducible higher than expected vitros amon quality control results from two levels of non-vitros control fluids using vitros amon microslides on a vitros 5,1 fs chemistry system. Level 1 result: 98. 7 umol/l vs. Expected 31. 2 umol/l; level 3 result: 307, 309 umol/l vs. Expected 240 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected. There were no allegations of patient harm. This report is number two of two mdr's for this event. Two 3500a forms are being submitted for this event as two 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 | 1319809-2015-00108 |
| MDR Report Key | 5123886 |
| Date Received | 2015-10-02 |
| Date of Report | 2015-10-02 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-09-03 |
| Device Manufacturer Date | 2015-04-23 |
| Date Added to Maude | 2015-10-02 |
| 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 |
| 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 AMON SLIDES |
| Generic Name | IN-VITRO DIAGNOSTICS |
| Product Code | JID |
| Date Received | 2015-10-02 |
| Catalog Number | 1726926 |
| Lot Number | 1014-0239-3213 |
| Device Expiration Date | 2016-10-01 |
| 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 | 2015-10-02 |