MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-05-22 for LIPASE COLORIMETRIC ASSAY 03029590322 manufactured by Roche Diagnostics.
[75612549]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[75612550]
The customer received questionable lipc lipase colorimetric assay results for one patient sample. The customer used cobas 6000 c (501) module serial number (b)(4). The initial result was 578 ui/l with a data flag. The repeat result with an automatic dilution was 827 ui/l. With a manual 1:20 dilution, the result was 896 ui/l. The result of 827 ui/l was reported to the doctor who decided to send the patient to the hospital. There another sample was drawn and the lipase result on another cobas 6000 c (501) module was 63 ui/l. The hospital called the laboratory who repeated the first sample and the result was 854 ui/l. On (b)(6) 2017, the first sample was sent to the hospital with results of 565 ui/l with a data flag, 974 ui/l with a data flag, and 963 ui/l. There was no allegation of an adverse event. It was suspected there was contamination or a mis-identification of the first sample. Other assays were unaffected.
Patient Sequence No: 1, Text Type: D, B5
[86996286]
Additional information was received for the complaint. The customer believes the high results to be correct. The customer did not believe that the suspect sample was mislabeled because all other parameters were reproducible. Contamination of the patient sample is not likely as the high results were confirmed several times. The second sample was drawn less than 24 hours after the first sample. Pancreatitis was excluded for the patient because other enzymes remained normal. No medication was given to the patient. As calibration and qc data was acceptable, a general reagent issue was not suspected. Interference in the sample was unlikely as the second sample from the patient had a result in the normal range.
Patient Sequence No: 1, Text Type: N, H10
[132591527]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01058 |
| MDR Report Key | 6581117 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-22 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-04-29 |
| Date Mfgr Received | 2017-05-02 |
| Date Added to Maude | 2017-05-22 |
| 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 | LIPASE COLORIMETRIC ASSAY |
| Generic Name | LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE |
| Product Code | CHI |
| Date Received | 2017-05-22 |
| Model Number | NA |
| Catalog Number | 03029590322 |
| Lot Number | 205954 |
| ID Number | NA |
| Device Expiration Date | 2017-12-31 |
| 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 | 2017-05-22 |