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 2018-06-13 for POTASSIUM ELECTRODE COBAS INTEGRA 400/700/800 21029355001 manufactured by Roche Diagnostics.
[111020524]
Unique identifier (udi)#:(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[111020525]
The customer received questionable high ise indirect gen. 2 potassium results for one patient sample from cobas integra 400 plus serial number (b)(4). The initial results were 6. 37 mmol/l and 6. 54 mmol/l. The result of 6. 37 mmol/l was reported outside of the laboratory. The patient's physician complained about the result and the customer sent the sample to another laboratory that used a cobas 6000 c (501) module. The results were 5. 74 mmol/l and 5. 70 mmol/l. The customer repeated the sample on the cobas integra 400 plus and the results were 5. 64 mmol/l, 7. 29 mmol/l, and 7. 22 mmol/l. There was no allegation of an adverse event. The customer performed precision testing which was acceptable. The customer suspected there was an interference in the sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01878 |
| MDR Report Key | 7595433 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-13 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-05-28 |
| Date Added to Maude | 2018-06-13 |
| 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 | AVL SCIENTIFIC CORP. |
| Manufacturer Street | 33 MANSELL COURT NA |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30076 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POTASSIUM ELECTRODE COBAS INTEGRA 400/700/800 |
| Generic Name | ELECTRODE, ION SPECIFIC, POTASSIUM |
| Product Code | CEM |
| Date Received | 2018-06-13 |
| Model Number | NA |
| Catalog Number | 21029355001 |
| Lot Number | ASKU |
| 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 | 2018-06-13 |