MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-16 for ANALYTICAL P MODULE 03261603001 manufactured by Roche Diagnostics.
[1486341]
The user stated that a sample run for a standard newborn total bilirubin test gave a result of 23. 0 mg/dl with data flag. The result was reported and was questioned by the doctor. The analyzer automatically repeated the sample with a result of 12. 1 mg/dl. The user also manually repeated the same sample in the same cup and it generated a result of 12. 1 mg/dl with data flag. The user generated a corrected report with value of 12. 1 mg/dl. The patient was not affected by the first result as the doctor called to check the result. The total bilirubin reagent lot number was 61734901 the user stated they found large and small particles and a yellow discoloration in the r2 reagent. The field service representative confirmed the cause was the particles and yellow color in the r2 reagent. He checked the sample and reagent systems for proper operation and checked the rinse mechanism operation. The user replaced the reagent. To verify the analyzer operation, a precision test was performed with acceptable results.
Patient Sequence No: 1, Text Type: D, B5
[1596945]
Reporter alleged obtaining the results of 91 mg/dl and 45 mg/dl back to back within 10 minutes on the aviva system. Reporter stated that she had some hypoglycemic symptoms and self-treated with food and drink. No other actions were reported taken or treatment received. No adverse event reported. A request was made for the return of the affected product.
Patient Sequence No: 1, Text Type: D, B5
[8486273]
.
Patient Sequence No: 1, Text Type: N, H10
[8581154]
Investigation of the event determined the precipitate in the r2 reagent did not affect the results. The precipitate in the r2 reagent is a known phenomenon and is described in the package insert. An instrument issue could be excluded based on the quality control being within the expected range. A pipetting issue, which might have been caused by pre-analytics issue was assumed to the reason for the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-01617 |
| MDR Report Key | 1631069 |
| Report Source | 05,06 |
| Date Received | 2010-03-16 |
| Date of Report | 2010-07-29 |
| Date of Event | 2010-02-24 |
| Date Mfgr Received | 2010-02-24 |
| Date Added to Maude | 2010-07-29 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| 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 P MODULE |
| Generic Name | CLINCAL CHEMISTRY ANALYZER |
| Product Code | JFM |
| Date Received | 2010-03-16 |
| Model Number | NA |
| Catalog Number | 03261603001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2010-03-16 |