MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-17 for LIPC LIPASE COLORIMETRIC 07041918190 manufactured by Roche Diagnostics.
[73125007]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[73125008]
A clinician stated that they received high test results using the lipc lipase colorimetric assay on the cobas 8000 c (701) module (c701) for patients who are taking the drug azathioprine. No patient information or test results were provided. The clinician stated that the test results did not match the clinical pictures of the patients. No further information was provided. There was no allegation of an adverse event. The c701 serial number is (b)(4). Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
[75019057]
A specific root cause for this event could not be identified. Additional information was requested for investigation but was not provided. Azathioprin is not listed in the common panel of drugs which are tested prior to the introduction of a new assay; therefore, the drug is not listed in the product labeling as a limitation. The investigation identified information indicating pancreatitis is an adverse reaction of taking azathioprin; however, this was not accepted by the clinician.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00795 |
| MDR Report Key | 6497590 |
| Date Received | 2017-04-17 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-23 |
| Date Added to Maude | 2017-04-17 |
| 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 | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPC LIPASE COLORIMETRIC |
| Generic Name | LIPASE TEST SYSTEM |
| Product Code | CHI |
| Date Received | 2017-04-17 |
| Model Number | NA |
| Catalog Number | 07041918190 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-17 |