MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT I2000SR ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number 03M74-97

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

Patient identifier did not contain enough spaces for enitre id.The entire id is (b)(6).(b)(4).A followup report will be submitted when the evaluation is complete.Evaluation in process.

Event Description

The account generated repeatedly reactive architect (b)(6) combo results on a post-mortem sample id (b)(6) (5.5, 1.7, 1.6,1.6, 1.7 s/co) that tested nonreactive on another architect analyzer.The sample was also (b)(6) with western blot and rna testing.The post mortem sample was screened for bone transplantation.Bones, tissues and other transplantation materials were lost due to the (b)(6) architect (b)(6) combo results.No specific donor information is known.No impact to recipients was reported.

Manufacturer Narrative

Upon retrospective review, discovered date of event was inadvertently entered incorrectly on the initial report.This report to update date of event to (b)(5) 2015.An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Manufacturer Narrative

Additional information was provided during evaluation: reactive architect hiv ag/ab combo results were also obtained on a third architect instrument by using the same reagent lots.This instrument is utilized for clinical studies performed and managed by an abbott clinical studies coordinator.The two post mortem samples were run on this architect instrument for troubleshooting purposes only.No issues were observed with "normal" samples or controls performed on the three architect i2000sr analyzers.An evaluation was performed for both the architect i2000sr analyzer and reagent lots.Architect hiv ag/ab combo evaluation: a review of the product labeling concluded that the issue is sufficiently addressed.The tracking and trending report review determined that there are no related adverse or non-statistical trends for the reagent lots involved in this event and no non-conformances and deviations associated with the affected reagent lots have been identified.A retained reagent kit of lot 54325li00 was tested in a specificity and sensitivity setup.Results of this setup did not implicate that the specificity or sensitivity performance of the lot is negatively impacted.The reagent kit showed normal performance without false reactive results.Additionally, the specificity performance were tested with lot 53118li00 and no (b)(6) were obtained.Based on this data, the performance of the architect hiv ag/ab combo reagent lot 53110li00 and 54325li00 is acceptable.Architect i2000sr evaluation: the field service engineer (fse) proactively cleaned and replaced several parts on the architect i2000sr.No subsequent occurrences of discrepant results were documented after the part replacements and cleaning of the optics.A review of the architect isr05922 service history was performed.No additional contributing factors on or around the date of the event were identified, and no subsequent occurrences of discrepant results were found after the cleaning of the optics and replacement of multiple parts by the fse.The architect system operations manual addresses operational precautions and limitations and addresses probable causes and corrective actions for the troubleshooting of discrepant results.A review of the architect product monitoring review found no similar issues as described in this complaint, and no trend associated with the architect i2000sr erratic result rate was identified.Based on the available information, there is insufficient evidence to reasonably suggest a malfunction of the architect i2000sr.The evaluation did not identify a specific reason, why the customer experienced this problem, but a possible explanation may be that the reactive results were due to sample integrity issues or due to the colour (almost black) of the affected samples.According to the package insert of the assay an important factor to obtain consistency in results is the quality of the sample.Based on this data, it is concluded that the architect hiv ag/ab combo reagent lots, identified in this complaint are performing acceptably, and there is no indication of a deficiency of the architect i2000sr or the various i2000sr parts replaced and/or cleaned.

• Brand Name: ARCHITECT I2000SR ANALYZER
• Type of Device: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5258548
• MDR Text Key: 32451724
• Report Number: 1628664-2015-00309
• Device Sequence Number: 0
• Product Code: NHS
• Reporter Country Code: NL
• PMA/PMN Number: K983212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03M74-97
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/22/2015; 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability