MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2007-08-10 for ARCHITECT LH 6C25-22 manufactured by Abbott Laboratories.
[673003]
The customer stated, that the lh control values, run on the architect analyzer, is out of range high. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[7911117]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2007-00208 |
| MDR Report Key | 891709 |
| Report Source | 01,04 |
| Date Received | 2007-08-10 |
| Date of Report | 2007-08-08 |
| Date of Event | 2006-09-21 |
| Date Mfgr Received | 2007-08-08 |
| Date Added to Maude | 2007-09-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-11/29/06-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT LH |
| Generic Name | CMIA FOR THE QUANTITATIVE DETERMINATION OF HUMAN LUTEINIZING HORMONE |
| Product Code | CEP |
| Date Received | 2007-08-10 |
| Model Number | NA |
| Catalog Number | 6C25-22 |
| Lot Number | 33198M200 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 877528 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-10 |