Catalog Number 08D06-28 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Code Available (3191)
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Event Date 01/22/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and specificity testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.No patient sample was available for return, therefore clinical specificity testing of negative control replicates was performed using in-house retained kits stored at the recommended storage condition.Specificity testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.
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Event Description
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The customer experienced a (b)(6) syphilis result on the architect i1000sr analyzer.The following data was provided: (b)(6) tested (b)(6) 2016 initial 1.20, repeat 1.39 s/co confirmation testing on other methods on an unknown date resulted as follows: zeus fta-abx (b)(6); fufirebio tppa (b)(6) <80; bd macro-vue rpr (b)(6) <1.The femoral head donor material was rejected.The sample was collected immediately prior to surgery.The sample is from a living donor undergoing routine hip replacement at a public hospital.Note: this same issue, same donor, same sid is also being reporting in manufacturing report number 3002809144-2016-00059 for a second suspect medical device (lot number) which generated the initial architect value.
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Manufacturer Narrative
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The conclusion code was corrected to (b)(4).The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended, however, no systemic issue or product deficiency was identified.
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Search Alerts/Recalls
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