MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-02-08 for ARCHITECT I2000SR ANALYZER 3M74-01 manufactured by Abbott Manufacturing, Inc..
[1962544]
The customer reports that a false positive architect cmv igg assay result (22. 8 au/ml) was generated on a liver transplant recipient. Before the surgery, a new sample was taken and tested and generated a negative result (1. 3 au/ml). The initial sample was retested and generated a negative result (2. 0 au/ml). All previous samples taken from this patient were then retested and all generated negative results. The samples also generated negative results with a non- abbott methodology. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8962330]
(b)(4). An investigation is in process. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[9224768]
(b)(4). The purpose of this evaluation is to investigate the performance of the architect cmv-igg reagent kit 6c15- 25 (lot 92348lf00; expiration date 04 october 2011). A retained in-house file sample of the architect cmv-igg reagent kit pack (lot 92348lf00) was used for testing. Performance testing was carried out using an in-house sample of architect cmv igg reagent (list 6c15-25, lot 92348lf00). The architect cmv igg torch negative panel was used to assess the acceptance criteria (the panel is serum based and thus mimics patient samples). An architect cmv igg assay calibration was successfully generated and control material passed, thus validating the calibration curve. Ten replicates of the architect cmv igg torch negative panel were assessed on an architect analyzer against the suspect reagent lot. The reagent lot returned results which met the specified limits, demonstrating that the reagent is meeting performance claims. The data forwarded by the customer was also reviewed. The cause of the specific discrepant patient result specified in the customer complaint was not able to be determined. It should also be noted that the control results reported by the customer met package insert specifications indicating that the reagent is performing acceptably. A review was also carried out of the testing performed by the quality control laboratory prior to approving the architect cmv igg reagent 6c15-25, lot 92348lf00 for sale. All kit release specifications were met, and no issues were identified. Review of the device history records did not identify any issues related to the customer complaint that indicate that there is a product deficiency. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The architect cmv igg reagent package insert and the architect i2000sr system operations manual both contain information to address the customer's current issue. Based on the results of the current investigation, it was determined that the architect cmv igg reagent, list number 6c15-25, lot number 92348lf00, identified in the complaint is performing acceptably. No malfunction of the product was determined and no additional issues were identified during the investigation of this complaint. Review of complaint tracking and trending; field service intervention.
Patient Sequence No: 1, Text Type: N, H10
[17602480]
(b)(4). The evaluation began with a review of the architect i2000sr analyzer's event logs, which did not reveal any questionable data. An abbott field service engineer (fse) was on site for planned/preventive maintenance and considered the instrument to be in perfect condition; however, three parts were replaced proactively on the analyzer in conjunction with the scheduled planned/preventive maintenance. No further instrument service calls have been initiated for this analyzer since the initial call. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The architect system cmv igg assay package insert (ln: 6c15 (p/n 48-3349/r4, december 2008)) and the architect system operations manual (p/n 201837-108, january 2010) both contain information to address the customer's current issue. Results of the current evaluation failed to identify a single definitive cause for the customer's issue. Review of complaint tracking and trending; field service intervention.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2011-00062 |
| MDR Report Key | 1981715 |
| Report Source | 01 |
| Date Received | 2011-02-08 |
| Date of Report | 2010-01-28 |
| Date of Event | 2011-01-11 |
| Date Mfgr Received | 2011-03-25 |
| Device Manufacturer Date | 2007-06-04 |
| Date Added to Maude | 2012-01-13 |
| 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 MANUFACTURING, INC. |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | OMI |
| Date Received | 2011-02-08 |
| Catalog Number | 3M74-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-08 |