MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2007-07-26 for ARCHITECT LH 6C25-27 manufactured by Abbott Laboratories.
[15033308]
The customer stated that while running the architect i2000sr, error code #1227 (assay (lh)number(641) calibration failure, fit concentration too high for cal f) generated before and after calibration using the lh assay reagent. There was no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5
[15305823]
An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1415939-2007-00202 |
MDR Report Key | 885309 |
Report Source | 01,05 |
Date Received | 2007-07-26 |
Date of Report | 2007-02-06 |
Date of Event | 2007-02-06 |
Date Mfgr Received | 2007-02-06 |
Date Added to Maude | 2007-08-21 |
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-09YG, APGC-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 | 2007-07-26 |
Model Number | NA |
Catalog Number | 6C25-27 |
Lot Number | 33198M201 |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
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 | 864866 |
Manufacturer | ABBOTT LABORATORIES |
Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2007-07-26 |