MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-05 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[3459249]
The customer received analyzer alarms and discovered questionable results for ck-mb, troponin i and n-terminal pro b-type natriuretic peptide (pro-bnp) for an unknown number of patient samples. Of the data provided, only the results for the following four patient samples were discrepant and reported outside the laboratory. Patient sample 1 initial troponin i result was 25. 00 ng/ml with a data flag. The repeat result on the same analyzer with a 1:10 dilution was 38. 43 ng/ml with a data flag. The sample was repeated on cobas e601 analyzer serial number (b)(4) and the result was 25. 00 ng/ml with a data flag. The repeat result with a 1:10 dilution was 137. 6 ng/ml. The patient was not adversely affected. Patient sample 2 was from a (b)(6) female patient. The initial pro- bnp result was 56. 65 pg/ml. The repeat result on cobas e601 analyzer serial number (b)(4) on (b)(6) 2013 was 157. 1 pg/ml. The repeat result on the original cobas e601 analyzer on (b)(6) 2013 was 157. 1 pg/ml. The patient was not adversely affected. Patient sample 3 was from a (b)(6) female patient. The initial troponin i result on cobas e601 analyzer serial number (b)(4) was 14. 83 ng/ml with a data flag. On (b)(6) 2013, the sample was repeated on cobas e601 analyzer serial number (b)(4) and the result was 25. 00 ng/ml with a data flag. The repeat result on the same analyzer with a 1:10 dilution was 48. 69 ng/ml with a data flag. The patient was not adversely affected. Patient sample 4 was from a (b)(6) male patient. The initial troponin i result was 1. 89 ng/ml. The repeat result was <0. 300 ng/ml. This patient was heparinized based on the initial troponin i result. The patient had a history of gi bleeds and a cardiac consult was ordered and heart cath scheduled. The customer did not know if the heart cath was peformed or if the patient had any complications based on erroneous result or his current status. The troponin i reagent lot number was 17026101 with an expiration date of (b)(6) 2014. The pro-bnp reagent lot number was 17057403 with an expiration date of (b)(6) 2014. The field service representative could not find a cause. He ran a successful photomultiplier tube (pmt) high voltage adjust and ran successful performance testing, blankcell calibration and precision check results on the affected assays.
Patient Sequence No: 1, Text Type: D, B5
[10794275]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-03388 |
| MDR Report Key | 3147383 |
| Report Source | 05,06 |
| Date Received | 2013-06-05 |
| Date of Report | 2013-06-05 |
| Date of Event | 2013-05-11 |
| Date Mfgr Received | 2013-05-31 |
| Date Added to Maude | 2013-06-05 |
| 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 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 Country | JA |
| 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 | COBAS 6000 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JLB |
| Date Received | 2013-06-05 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| 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 | 2013-06-05 |