MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-12-27 for ARCHITECT ITHEOPHYLLINE 1P29-25 manufactured by Abbott.
[1745811]
The customer stated an architect i1000sr analyzer generated discrepant theophylline results for one patient sample. The architect analyzer generated an initial theophylline result of 115. The next day the patient was redrawn and a theophylline result of 6. 38 was generated. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8869642]
(b)(4). A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[9101371]
(b)(4). Further investigation of the customer issue included a review of the complaint text, testing of liquicheck controls, and a search for similar complaints. The original equipment manufacturer performed value assignment testing on the liquicheck immunoassay plus control, lot 40750 with lots 02209i000 and 01109b000. Both reagent lots were tested with two calibrator lots on two different architect instruments using four replicates of each liquickeck levels 1,2 and 3 along with two replicates of each internal control. No testing issues were noted and no erroneous liquicheck values were observed. Tracking and trending found no abnormal activity for the issue under investigation. Specimen handling is believed to be the source of the discrepancy. The investigation indicates that the product is effective and is performing acceptably.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002809144-2010-00045 |
| MDR Report Key | 1938229 |
| Report Source | 01 |
| Date Received | 2010-12-27 |
| Date of Report | 2010-12-14 |
| Date Mfgr Received | 2011-02-17 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2012-01-23 |
| 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 | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT |
| Manufacturer Street | MAX-PLANCK-RING 2 65205 WIESBADEN |
| Manufacturer City | DELKENHEIM 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT ITHEOPHYLLINE |
| Generic Name | FOR THE MEASUREMENT OF THEOPHYLLINE IN HUMAN SERUM OR PLASMA |
| Product Code | LGS |
| Date Received | 2010-12-27 |
| Catalog Number | 1P29-25 |
| Lot Number | 02209I000 |
| Device Expiration Date | 2011-03-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT |
| Manufacturer Address | MAX-PLANCK-RING 2 65205 WIESBADEN DELKENHEIM 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-27 |