MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-06-04 for ARCHITECT SIROLIMUS 1L76-25 manufactured by Abbott Laboratories.
[1507901]
The abbott architect sirolimus reagent lot 80162m100 is exhibiting higher than normal complaint activities related to barcode read errors, due to the print quality of the barcode label. The inability of the architect analyzer to read the reagent barcode label does not result in a shift in patient results (no change to bias, precision and/or no impact to sample identification). If a reagent barcode is unreadable by the analyzer, patient sample testing cannot occur, as the reagent is unusable. If the analyzer was able to read the barcode after customer intervention, the reagent pack would be usable. In either case, there would be a delay in generating patient results. Patient results may also be delayed up to 24 hours when replacement material is needed. A product recall has been issued and reported under 21cfr806 for the architect sirolimus reagent to the (b)(4) on (b)(4) 2010. Abbott has not received any reports of adverse events related to this issue.
Patient Sequence No: 1, Text Type: D, B5
[8653992]
(b)(4). Concomitant medical products: architect i1000sr analyzer, list # 1l86-01. Architect i2000 analyzer, list # 8c89-01. Architect i2000sr analyzer, list # 3m74-01. 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)(6) 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.
Patient Sequence No: 1, Text Type: N, H10
[19271563]
Patient Sequence No: 1, Text Type: D, B5
[19515268]
(b)(4). Architect i1000sr analyzer, list # 1l86 architect i2000 analyzer, list # 8c89 architect i2000sr analyzer, list # 3m74 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)(6) 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
[21013276]
Patient Sequence No: 1, Text Type: D, B5
[21227029]
(b)(4). Architect i1000sr analyzer, list # 1l86. Architect i2000 analyzer, list # 8c89. Architect i2000sr analyzer, list # 3m74. 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 lots were affected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2010-00344 |
| MDR Report Key | 1710696 |
| Report Source | 07 |
| Date Received | 2010-06-04 |
| Date of Report | 2010-05-27 |
| Date of Event | 2010-05-27 |
| Date Mfgr Received | 2010-11-24 |
| 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 | 2010-06-04 |
| Catalog Number | 1L76-25 |
| Lot Number | 80162M100 |
| Device Expiration Date | 2011-05-03 |
| Operator | OTHER |
| 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 | 2010-06-04 |