MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-01-23 for ANALYTICAL E MODULE 03739040001 manufactured by Roche Diagnostics.
[19927163]
The customer received questionable insulin results on their modular e170 analyzer. On (b)(6) 2011, the patient was taken to the hospital for low blood glucose shock. After this, the patient stopped using insulin. All the results provided were from fasting samples. Of the data provided, the results for the sample from (b)(6) 2012 are considered discrepant. The patient's first sample taken on (b)(6) 2011 and tested on (b)(6) 2011 had an insulin result of 2113 pmol/l. The patient's second sample taken (b)(6) 2011 had an insulin result of 1493 pmol/l on the e170 analyzer. The patient's third sample taken on (b)(6) 2012 had an insulin result of 1383. 5 pmol/l on the e170 analyzer. On (b)(6) 2012, the third sample was repeated on the e170 analyzer and the result was 1335 pmol/l. The sample was then diluted 1:10 and the result was 1540 pmol/l. On (b)(6) 2012, the third sample was tested on a siemens advia centaur and the result was 202. 13 pmol/l. The results from the e170 analyzer were reported outside the laboratory. A ct scan was administered to the patient to determine why the patient had such high insulin levels even after he stopped taking insulin. The patient's current condition is stable. There were no adverse events from the discrepant results. The insulin reagent lot number was 162791 and the expiration date was not provided.
Patient Sequence No: 1, Text Type: D, B5
[20274789]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[22132028]
Without the sample for investigation, the root cause could not be determined. The calibration and quality control data provided were well within specification, no issue with the reagent is evident. It is possible there were antibodies to insulin present, which is not uncommon in people treated for a long time with bovine, porcine, and human insulin. The possible antibody interferences are listed in the package insert.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-00386 |
| MDR Report Key | 2425267 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-23 |
| Date of Report | 2012-04-20 |
| Date of Event | 2012-01-03 |
| Date Mfgr Received | 2012-01-04 |
| Date Added to Maude | 2012-01-23 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANALYTICAL E MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CFP |
| Date Received | 2012-01-23 |
| Model Number | NA |
| Catalog Number | 03739040001 |
| Lot Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-23 |