MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-22 for ARCHITECT SIROLIMUS 1L76-25 manufactured by Abbott Laboratories.
[1634802]
The customer observed architect sirolimus reagent barcode read errors when reagent lot 80126m00 was in use. The customer stated that the barcode read errors were observed only with the sirolimus reagent and was able to run the assay after cleaning the barcode reader. The customer was sent a replacement new lot of reagent which resolved the issue. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[8618843]
(b)(4), concomitant medical device: architect i2000sr analyzer, list # 3m74-01 (b)(4). The cause of the architect sirolimus reagent barcode read error was poor print quality from a single barcode printer. A product recall was issued on (b)(4) 2010 for architect sirolimus reagent lot 80162m100 and abbott customers were notified to discontinue and/or destroy any remaining inventory of this lot. No other lots of architect sirolimus reagent were affected. 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
[8782184]
(b)(4). Concomitant medical products: architect i2000sr analyzer, list # 3m74-01, (b)(4). The cause of the architect sirolimus barcode read error was poor print quality from a single barcode printer. A product recall was issued on (b)(4) 2010 for architect sirolimus reagent lot 80162m100 and abbott customers were notified to discontinue and/or destroy any remaining inventory of this lot. No other architect sirolimus reagent lots were affected.
Patient Sequence No: 1, Text Type: N, H10
[17059236]
(b)(4). Architect i2000sr analyzer, list #3m74-01, (b)(4). The cause of the architect sirolimus barcode read error was poor print quality from a single barcode printer. A product recall was issued on 5/27/10 for architect sirolimus reagent lot 80162m100 and abbott customers were notified to discontinue and/or destroy any remaining inventory of this lot. No other architect sirolimus reagent lots were affected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2010-00362 |
| MDR Report Key | 1731420 |
| Report Source | 05 |
| Date Received | 2010-06-22 |
| Date of Report | 2010-04-29 |
| Date Mfgr Received | 2010-11-24 |
| Device Manufacturer Date | 2009-11-09 |
| Date Added to Maude | 2010-12-10 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-5/28/10-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT SIROLIMUS |
| Generic Name | CMIA FOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS IN HUMAN BLOOD |
| Product Code | NRP |
| Date Received | 2010-06-22 |
| Catalog Number | 1L76-25 |
| Lot Number | 80162M100 |
| Device Expiration Date | 2011-05-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-22 |