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 2017-05-15 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[75178707]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75178708]
The customer initially stated that they were getting questionable results for a total of 6 patient samples tested for nh3l ammonia (nh3) on a cobas 6000 c (501) module - c501. Of these 5 samples, 4 had erroneous results. The first sample had an erroneous initial result that was reported outside of the laboratory. It was not clear if the second, third, and fourth samples had any erroneous results that were reported outside of the laboratory. A clarification has been requested. The first sample initially resulted as 69. 7 ug/dl and this value was reported outside of the laboratory. The sample was repeated as the patient had a previous value 99. 9 ug/dl on (b)(6) 2017. The repeat result of the sample was 88. 5 ug/dl. The sample was repeated a second time, resulting as 160. 9 ug/dl. The sample was also repeated on a cobas 8000 series analyzer, resulting as 184. 8 ug/dl. The second sample initially resulted as 48. 6 ug/dl on (b)(6) 2017. The sample was repeated on a cobas 8000 series analyzer, resulting as 82. 6 ug/dl on (b)(6) 2017. The third sample initially resulted as 50. 7 ug/dl on (b)(6) 2017. The sample was repeated on a cobas 8000 series analyzer, resulting as 78. 0 ug/dl on (b)(6) 2017. No adverse events were alleged to have occurred with these patients. The nh3 reagent lot number was 207830. The reagent expiration date was asked for, but not provided. The field service engineer cleaned the analyzer with bleach, changed the gear pump head, and changed a manometer. On (b)(6) 2017, the customer stated that they received an erroneous nh3 result for the fourth patient sample. The sample initially resulted as 98. 7 ug/dl and repeated as 119. 2 ug/dl. The sample was also repeated on a cobas 8000 series analyzer, resulting as 134. 9 ug/dl.
Patient Sequence No: 1, Text Type: D, B5
[79043806]
On (b)(6) 2017, the first patient sample had a ggt result of 2252. No units of measure were provided. A reagent and hardware issue can be excluded since control recovery is ok and the calibration was successful prior to and after the event. The root cause of the event is incorrect sample preparation. Labeling instructs the customer that ammonia concentrations can increase in vitro due to breakdown of nitrogen-containing plasma components. One known source of ammonia formation at storage higher than -38? C is an increased g-glutamyltransferase activity leading to decomposition of glutamine.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01006 |
| MDR Report Key | 6567290 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-15 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-04-26 |
| Date Mfgr Received | 2017-04-27 |
| Date Added to Maude | 2017-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 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 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JIF |
| Date Received | 2017-05-15 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-15 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-15 |