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 2018-03-13 for AVL CALCIUM ELECTRODE 03110354180 manufactured by Roche Diagnostics.
[102750606]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[102750607]
The customer received erroneous avl ca++ electrode (ca++) results for 3 patient samples on an electrolyte analyzer w/o starterkit 9180 (avl) serial number (b)(4). For patient 1 the initial ca++ result was 12. 0 mg/dl and the repeat result was 12. 35 mg/dl. The ca++ result was 1. 18 mg/dl from the same sample on an abl800 gasometer. For patient 2 on (b)(6) 2018 the initial ca++ result of 12. 89 mg/dl. The ca++ result was 1. 06 mg/dl from the same sample on an abl800 gasometer. A new sample was collected and the ca++ result of 11. 5 mg/dl. The ca++ result was 1. 02 mg/dl with the new sample on an abl800 gasometer. For patient 3 on (b)(6) 2018 the initial ca++ result of 15. 18 mg/dl. The ca++ result was 1. 43 mg/dl from the same sample on an abl800 gasometer. The results on the abl800 gasometer were considered to be correct. No erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The qc from both methods were within the expected range. There were no discrepancies observed for other patient samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00786 |
| MDR Report Key | 7333427 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-13 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-03-13 |
| 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 | AVL CALCIUM ELECTRODE |
| Generic Name | ELECTRODE, ION SPECIFIC, CALCIUM |
| Product Code | JFP |
| Date Received | 2018-03-13 |
| Model Number | NA |
| Catalog Number | 03110354180 |
| Lot Number | 21573547 |
| 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 | 2018-03-13 |