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 2018-03-22 for FERRITIN 03528995190 manufactured by Roche Diagnostics.
[103688687]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103688688]
The customer complained of discrepant results for 1 patient tested for ferritin gen. 2 (ferr2) on a cobas integra 400 plus. The patient was initially tested on (b)(6) 2018 on the integra 400 plus and the ferr2 result was 2228. 4 ng/ml with a data flag. This result was reported outside of the laboratory. This sample was repeated and the result was 2293. 7 ng/ml with a data flag. A new sample was obtained on (b)(6) 2018 and the ferr2 result from the integra 400 plus was 2,420. 0 ng/ml accompanied by a data flag invalidating the result. On (b)(6) 2018 a new sample was obtained and the result from a cobas 6000 e 601 module was 62. 7 ng/ml. This result was not reported outside of the laboratory. On (b)(6) 2018 this sample was repeated on the integra 400 plus and the result was 2205. 3 ng/ml with a data flag. The samples run on the integra 400 were automatically diluted 1:5 by the instrument as the measuring range is 10? 484 ng/ml. It is not clear which results the customer believes to be correct. The customer initially questioned the high ferr2 results because the patient had no clinical history of elevated ferritin and had been checked for stigma of sickle cell anemia. The customer later stated they performed a saturation of transferrin and the results were high causing them to think the patient may have hemodialysis. The customer stated they now think the initial result of 2228. 4 ng/ml was correct. There was no allegation that an adverse event occurred. The integra 400 plus serial (b)(4). The e601 module serial number was not provided. Calibration, qc and precision test results were all acceptable on the integra 400 plus instrument. As part of troubleshooting, the field service engineer (fse) visited the customer site and manually diluted the sample 1:10 and the result was 1480 ng/ml after calculation. The high ferr2 result was confirmed in comparison to the e601 result. The fse went to another site using the integra 400 and the sample was repeated again with an initial result of > 489 ng/ml and after the automatic dilution of 1:5 the result was 2189 ng/ml. A manual dilution of 1:10 produced a result of 1490 ng/ml after calculation. The fse went to another site where the customer uses an e601 module and the result was 72. 2 ng/ml. Based on the information available, there does not seem to be an instrument or materials issue with the integra 400 plus instrument. An interference in the sample is believed to be the root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00895 |
| MDR Report Key | 7363111 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-22 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-02-26 |
| Date Added to Maude | 2018-03-22 |
| 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 | FERRITIN |
| Generic Name | RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN |
| Product Code | JMG |
| Date Received | 2018-03-22 |
| Model Number | NA |
| Catalog Number | 03528995190 |
| Lot Number | 232126 |
| 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 | 2018-03-22 |