Model Number LCT, TP LDR 33G 100CT50/CASE MULTICOLOR |
Device Problems
Product Quality Problem (1506); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2022 |
Event Type
malfunction
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Event Description
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Consumer reported complaint for the 33g trueplus lancets.Distributor contacted manufacturer on behalf of the customer; distributor internal report reference number: (b)(4) manufacturer contacted customer via telephone.Customer stated that the multi-color lancets had a "big blob" of plastic on the tip and that they are unable to pierce her skin.Customer did not have any of the lancets; customer had returned to pharmacy.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
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Manufacturer Narrative
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Internal report reference number: (b)(4).Lancets were not returned for evaluation.Manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated the pharmacy had issued her a refund and that she had purchased different lancets.
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Manufacturer Narrative
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Sections with additional information as of 21-june-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: lancets were not returned for evaluation.Complaint was forwarded to supplier quality based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by the manufacturer.No abnormalities observed on retain samples.Most likely underlying root cause: most likely underlying root cause: mlc-009: use error caused or contributed to event.
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Search Alerts/Recalls
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