MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-06 for LIPC LIPASE COLORIMETRIC manufactured by Roche Diagnostics.
[116865174]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[116865175]
The customer questioned high results for 1 patient tested for lipase on a cobas 6000 c (501) module. The patient had been tested for lipase on the c501 module initially with a result of 739 u/l. The sample was repeated on "another system" and the result was 733 u/l. On (b)(6) 2018 the patient was tested on the c501 module with a result of 981 u/l. This result was reported outside of the laboratory. The sample was sent to an external laboratory using the abbott method and the result was 150 u/l. The date of the event is either (b)(6) 2018. Clarification on this has been requested but not provided. There was no allegation that an adverse event occurred. The c501 module serial (b)(4). The customer suspects an interference in the sample affecting the results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02615 |
| MDR Report Key | 7751778 |
| Date Received | 2018-08-06 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-07-19 |
| Date Added to Maude | 2018-08-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | LIPC LIPASE COLORIMETRIC |
| Generic Name | LIPASE TEST SYSTEM |
| Product Code | CHI |
| Date Received | 2018-08-06 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| 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 | 2018-08-06 |