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Catalog Number 08057532190 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The analyzer serial number is (b)(6).The customer stated verbally that their qc recovery data was acceptable.The investigation is ongoing.
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Event Description
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There was an allegation of questionable crej2 creatinine jaffé gen.2 results for 1 patient on a cobas pro c 503 analytical unit.The customer questioned the patient's results as they noticed fluctuation across multiple samples and suspect a possible drug interference.On (b)(6)2023, the patient had a crej2 result of 61 umol/l.On (b)(6)2023, the patient had a crej2 result of 170 umol/l and a second result of 140 umol/l.On (b)(6)2023, the patient had a crej2 result of 296 umol/l and a second result of 235 umol/l.On (b)(6)2023, the patient had a crej2 result of 135 umol/l and a second result of 135 umol/l.On (b)(6)2023, the patient had a crej2 result of 57 umol/l and a second result of 272 umol/l.On (b)(6)2023, the patient had a crej2 result of 174 umol/l and a second result of 80 umol/l.On (b)(6)2023, the patient had a crej2 result of 81 umol/l and a second result of 63 umol/l.On (b)(6)2023, the patient had a crej2 result of 57 umol/l.On (b)(6)2023, the patient had a crej2 result of 62 umol/l.On (b)(6)2023, the patient had a crej2 result of 53 umol/l.
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Manufacturer Narrative
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The patient had the following albumin and crep2 (creatinine plus) results: on (b)(6) 2023, the patient had an albumin result of 26 g/l.On (b)(6) 2023, the patient had a crep2 result of 175 umol/l, a second crep2 result of 142 umol/l, and an albumin result of 27 g/l.On (b)(6) 2023, the patient had a crep2 result of 304 umol/l, a second crep2 result of 239 umol/l, and an albumin result of 25 g/l.On (b)(6) 2023, the patient had a crep2 result of 138 umol/l, a second crep2 result of 137 umol/l, and an albumin result of 22 g/l.On (b)(6) 2023, the patient had a crep2 result of 58.4 umol/l, a second crep2 result of 286 umol/l, and an albumin result of 26 g/l.On (b)(6) 2023, the patient had a crep2 result of 174 umol/l, a second crep2 result of 82.8 umol/l, and an albumin result of 29 g/l.On (b)(6) 2023, the patient had a crep2 result of 74 umol/l, a second crep2 result of 61.4 umol/l, and an albumin result of 25 g/l.On (b)(6) 2023, the patient had a crep2 result of 59.3 umol/l and an albumin result of 25 g/l.On (b)(6) 2023, the patient had a crep2 result of 58.7 umol/l and an albumin result of 25 g/l.On (b)(6) 2023, the patient had a crep2 result of 58.4 umol/l and an albumin result of 28 g/l.Medwatch field d10 and concomitant medical products have been updated.See attached data for patient medication information and diagnosis.The investigation is ongoing.
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Manufacturer Narrative
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The calibration and qc recovery data provided was acceptable.Based on the calibration and qc data, a general reagent issue could be excluded.The alarm trace showed qc out of range, abnormal aspiration, and photometer check alarms.The investigation did not identify a product problem.The root cause of the event could not be determined.
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Search Alerts/Recalls
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