MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-11 for VITROS CHEMISTRY PRODUCTS AMON SLIDES 1721869 manufactured by Ortho-clinical Diagnostics.
[36001117]
The investigation determined that a non-reproducible, lower than expected vitros amon quality control result was obtained on a vitros 5,1 fs chemistry system. The investigation was unable to determine a definitive assignable cause. However, user error due to improper use of reagent past its onboard stability is a likely assignable cause. Based on the information available, a vitros instrument issue cannot be completely ruled out as a contributing factor. The investigation was unable to determine a definitive assignable cause.
Patient Sequence No: 1, Text Type: N, H10
[36001118]
The customer obtained a non-reproducible, lower than expected vitros amon quality control result on a vitros 5,1 fs chemistry system. Qc lpv ii vitros amon result of 133. 7 mol/l vs. Expected result 176. 9 mol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action, should they occur undetected on patient samples. The customer stated that no vitros amon patient samples tested during the time frame of the event were in question. However, the investigation cannot rule out that patient sample were not 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. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2016-00002 |
| MDR Report Key | 5357561 |
| Date Received | 2016-01-11 |
| Date of Report | 2016-01-11 |
| Date of Event | 2015-12-08 |
| Date Mfgr Received | 2015-12-14 |
| Device Manufacturer Date | 2015-02-12 |
| Date Added to Maude | 2016-01-11 |
| 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 AMON SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JID |
| Date Received | 2016-01-11 |
| Catalog Number | 1721869 |
| Lot Number | 1015-0238-1246 |
| Device Expiration Date | 2016-08-01 |
| 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 | 2016-01-11 |